דרושים Assoc Dir Global Quality Function - ב-טבע ב-India, Bengaluru

• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Ensures timely and accurate data migration in collaboration with sites and Global IT / IT Quality
• Ensures timely review of CMC documentation in collaboration with Global R&D sites
• Defines team operating standards and ensures essential CORP and local procedures are followed based on knowledge of own discipline.
• Manages and supervises a team of up to 100 professional employees consisting of sr. managers, managers, authors reviewers and approvers.
• Is accountable for the performance and results of a teams within the function Global Quality GBS.
• Creates and adapts departmental plans and priorities to address resource and operational challenges.
• Ensures that decisions are guided by CORP policies, procedures and Global Quality´s business plan.
• Receives guidance from Senior Director Quality Strategy and Shared Services, SVP Global Quality, other Managers in Quality Strategy and Shared Services, Global R&D, Global IT, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites.

A.Review and approval of PQR’s

The owner of the function

• Review of Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products supplied by external vendors and manufactured at external manufactures
• Conduct review of (APRs) / Product Quality Reviews (PQRs) prepared by team members to ensure high quality of the reports prepared by the team.
• Recommend actions and communicate to stakeholder for identified actions as part of the review process to improve quality of products(CAPA)
• Approve Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) which do not require approval step by any other TEVA /non-TEVA stakeholder like QPs, RPs or FvPs.
• Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority.

B.Data Migration

• Ensure Data Migration is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of DM issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues of the DM team to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

C.R&D CMC Documentation
• Ensure review of CMC documents received from R&Ds is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

D.Quality Management Systems

The owner of the function

• Ensures that the local quality management system is maintained at GBS Quality function.
• Ensures that the local Quality Management System is compliant with respective regulatory guidelines and TEVA´s CORP QMS (Gap Assessments)
• Approves process of change controls and deviations
• Approves local SOP’s and its related documents.

E.Performance Management

• Monitors and compiles the KPI scores of the various business units and supports the team to improve their efficiency.
• Participates in the customers council meetings and supports the effectiveness of the councils.
• Leads or participates in the Monthly Quality Council and enhances the effectiveness and efficiency of it by suitable reports/metrices and continuous improvement.

The incumbent

• Approves Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.
• Reviews the training status of the team and regularly verifies that training was performed in time and successfully.
• Certifies trainers and self-inspectors to enable them to impart training and conduct self-inspection.

G.Miscellaneous Support

The owner of the function is responsible for

• Hiring of new Headcount and monitoring the Head count status
• Maintaining Employee Central and other relevant Master Data
• Liase with Finance related to the HC cost
• Responsible for approval of PR’s related to purchase of PQR’s.
• Review the invoicing cost involved with respect to the status.
• Approval of POs in SAP- for hiring and other requests like purchase orders for costs involved in updation of software
• Review monthly report to be presented to higher management

• More than 15 years of experience in QA / QC function in the pharmaceutical industry
• More than 5 years of experience in a managerial role
• Well-founded knowledge on worldwide cGxP regulations
• Excellent English language skills, other language skills could be helpful
• Very Good communication skills and ability to work in a matrix structure
• Very good knowledge of Computerised Systems in TEVA´s IT landscape (Track-Wise, SAP, LIMS, Global Insights, Glorya etc.)
• Good understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Mobility

VP Global Quality SMSO

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This incumbent

• Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
• Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
• Review of Instrument/Equipment Qualification records.
• Review of BMR.
• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
• Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
• Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
  Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

1. Review of CMC Documentation

• Review of Method Development / Validation protocols & reports.
• Review of Stability Study protocol, reports & grids.
• Review of Instrument / Equipment Qualification records.
• Review of Batch Manufacturing Records.
• Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
• Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
• Contemporaneous updation of SharePoint data base

1. Data requesting and Compilation of PQR’s

• Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
• Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
• Follow up with the CMO‘s for the receipt of data within time.
• Check quotation received from CMO and initiate PR/PO for QP’s approval.
• Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
• Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
• Contemporaneous updation of SharePoint data base

1. Quality Management Systems

• Initiate the process of change controls and deviations
• Preparation of local SOP’s and its related documents.
• Participate in self-inspection process

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 2 to 8 years of experience in QA / QC function in the pharmaceutical industry
• Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
• Basic knowledge on worldwide cGxP regulations
• Good English language skills, other language skills could be helpful
• Good communication skills
• Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
• Basic understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
• Hands-on experience on Review of Instrument/Equipment qualification records.
• Basic knowledge / hands on experience of review of BMR.
• Basic knowledge / hands on experience on Product Quality Reviews.

The Associate Director, Complex Gx, Regulatory Affairs serves as a strategic regulatory leader, responsible for independently guiding and executing all regulatory activities—both pre- and post-approval—for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. This role ensures regulatory compliance, drives operational excellence, and leads a team of regulatory professionals to deliver high-quality submissions and lifecycle management initiatives. The Associate Director acts as a key liaison with the FDA, internal cross-functional teams, and external partners. This role will also facilitate strategic alignment with FDA through early and proactive engagement during product development, enabling streamlined development pathways, mitigating regulatory risk, and accelerating time-to-market—ultimately increasing the likelihood of first-cycle approvals.

• Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays.
• Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Represent Regulatory Affairs in global and regional forums, contributing to strategic planning and regulatory alignment.
• Interpret and apply FDA regulations and guidance to both new and marketed products, ensuring compliance while fostering innovation.
• Develop and implement regulatory strategies aligned with global business objectives.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Lead departmental planning, resource management, and policy development.
• Mentor and develop regulatory staff, supporting leadership growth and succession planning.
• Foster a culture of transparency and open communication across all levels of the organization.
• Monitor and optimize key performance indicators (KPIs), including submission timelines, quality metrics, and team development goals.
• Communicate organizational updates and priorities clearly and effectively to the team.
• Manage departmental budgets related to regulatory submissions and administrative operations.
• Serve as a delegate for senior leadership in executive forums, representing the regulatory function.
• Identify and cultivate new opportunities that align with organizational goals and future capabilities.
• Support internal and external audits and regulatory inspections as required.
• Build and maintain strong working relationships with FDA project managers.

• Bachelor’s or Master’s degree (preferred) in Pharmacy, Life Sciences, or a related field (e.g., M.Sc., Ph.D.).
• Minimum 12+ years of pharmaceutical industry experience, including at least 8+ years in U.S. Regulatory Affairs with a focus on complex generic drug products including semi-solid, transdermal, and nasal spray generic drug products.
• At least 6 years of proven leadership experience managing regulatory teams and complex product portfolios.
• In-depth knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
• Proficiency with regulatory systems (e.g., Veeva, TrackWise) and electronic document management platforms (e.g., Wisdom, Glorya, Livelink, Knowledgetree).
• Solid understanding of pharmaceutical drug development processes.
• Demonstrated success in FDA interactions, with strong negotiation and influencing skills.
• Excellent verbal and written communication skills.
• Experience working in matrixed, multinational environments and with third-party partners.
• Lean Six Sigma certification or equivalent process improvement training is a plus.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• The Director reports directly to the Head of Global Statistics, Data Science, and Medical Writing (GSD) and serves as a member of the GSD Leadership Team. This role oversees GSD India-based employees across Data Management, Statistics, Programming, and Medical Writing, managing key administrative responsibilities such as timesheet approvals, time-off requests, performance evaluations, and career development. The Director collaborates with HR to resolve employee concerns and partners with global functional heads for resource planning and assignments. While functional project leads provide day-to-day guidance, the Director ensures team members receive clear direction and coaching to support successful execution. A core focus of the role is fostering a unified GSD India community that is well-integrated with the global organization.
• In addition to operational leadership, the Director brings deep expertise in data functions, drug development, and clinical research, including regulatory interactions both within and outside the U.S. They provide strategic guidance across compounds or therapeutic areas, offering critical thinking that influences clinical development programs, study design, and analysis. The Director is well-versed in drug development principles, innovative trial approaches, and relevant tools and software. Strong communication skills and the ability to influence cross-functional teams are essential, as this role has significant visibility and impact across drug development programs and senior leadership

• Provides strategic and scientific leadership to the clinical development, registration strategy, submission, health authority interactions, and medical affairs/market access plans for complex programs across multiple diseases
• Organizational leader that is a key contributor in defining and driving the line function strategy
• Leads and optimizes the contribution from the team(s) by collaborating and consulting with key partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills
• Strategic and/or managerial responsibilities for GSD India team across multiple programs/indications of Teva. Independently lead (large) programs and accountable for the GSD India deliveries and influence for the programs
• A modern drug development global leader – operate as a full partner to clinical and scientific leadership. Ensures effective partnership with other functions including clinical, regulatory and other strategic functions to drive quantitative decision sciences / making in drug development and enable successful impact on CDPs (Clinical Development Plan), programs and trials
• Interacts and manages KOLs/CROs and represents the company in external scientific and industry forums
• Is seen as a strategic Business partner involved in high-level decisions having an impact on the organization globally
• Drives GSD India Team it through the use of novel/innovative clinical trial designs and statistical or other data related methodology
• Becomes proficient in the knowledge of the therapeutic area and competitive landscape of the specified therapeutic area
• Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with GSD global team and Clinical Research personnel as needed
• Supports due diligence activities
• Forecasts and maintains budgets
• Primarily works at the TA / Functional Level
• Oversee direct reports; Oversee contingent workers and/or vendors; Provide training to others; Strategically analyze needs to manage resources and accountable for resource allocation
• Accountable for delivering assignments with quality and within timelines

• Ph.D./MS in Statistics/Biostatistics (or data related field or Medical Writing related field )
• MS with a minimum of 8 years of related experience; PhD with a minimum of 6 years of related experience

• Is responsible receiving, categorizing, trending, logging complaints for US market and coordinating the return of the complaint Samples for product quality related complaints from customers.
• This includes handling of complaints reported by US customers (patient, doctors, pharmacist, HCP or any other customers who use or handle Teva products) via live phone call (90%), email and voicemail etc.
• QAS team member need to be logged in Avaya Phone application between 6:30 PM IST (9:00 AM EST) to 2:30 AM IST (5:00 PM EST) to receive live phone calls related to complaints handling from US customers.
• The received complaints are processed in TrackWise application including classification into multiple categories (critical/non-critical) and also sending notifications to respective manufacturing /packaging sites located globally requesting investigation.
• Additional responsibilities include completion training in LMS (QAS process related) and STUDIUM tasks, handling reconciliation activities related to PV, complaint samples returned and participate in team meetings.
• Phone Etiquettes and Customer Service Skills:
  1. Positive Customer relationships with productive interactions related to Complaint issue, Gain better understanding of the issue, obtaining more information. Provide update on investigation status. Coordinating and checking the availability of Complainant Sample for return to investigating sites3. Strong communication skill in English language
  4. Patience and Empathy towards customers
  5. Attention to detail and problem-solving skills
  6. Multitasking ability

• Complaint Processing:
  Performs the functions associated with receiving, trending, logging, and coordinating the return of the complaint samples for product quality related Complaints. This includes complaints received via live phone call, email, and internet.
  Utilize knowledge and experience from processing of live complaint calls to lead by example.
• Assists QAS Intake team management in handling of QAS Intake team activities:
  Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions.
  Collaborate with QAS team to discuss and calibrate on different complaint scenarios on how records should be handled during weekly team meeting.
• Participate and contribute to the continuous improvement activities of the QAS group:
  Participate in the continuous improvement of the QAS Group to drive operational excellence by performing a variety of tasks and projects to increase compliance, efficiencies and effectiveness of actions within the Group.

• Bachelor of Science Degree in a scientific field preferably, Pharmacy, Chemistry, Micro-Biology, Life sciences, etc.
• Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate
• Understanding of Product Quality related Complaints and Adverse Events; Deviations/Investigations/Root Cause Analysis, CAPA;
• Data Integrity and TrackWise but not mandate.
• Excellent written and verbal communication skills in English Language
• Flexibility to work in continuous permanent night (6:30 PM to 2:30 AM IST)Availability to take phone calls with external customers continuously during the US business hours.

• Lead a team of network engineers and manages corporate projects and problem resolution requiring the participation of multiple specialized teams
• Researches, Implements, and maintains information technologies to increase LAN/WAN and Cloud based operational efficiencies and secure enterprise network.
• Designs, implements, and maintains highly available and fault tolerant network routing/switching/security infrastructure for the enterprise with minimal supervision.
• Infrastructure technologies include, but are not limited to: Client based SSL VPN, Site-to-Site IPSec VPN, DNS, DHCP, VoIP, SIP, H.323 video collaboration, firewall technologies, network load balancing technologies, network monitoring technologies, 802.11b/g/n wireless networks, and 802.3 based Ethernet networks.
• Assist to support day-to-day operations escalation and on-going network projects include hands-on activities • HLD & LLD documents design and writing
• Lead site level network projects working closely with site IT managers • Install, configure, analyze, and upgrade network equipment (including routers, switches, Data Center and SD-WAN equipment)
• Perform preventative maintenance for the network in global environment
• Provide troubleshooting expertise for network problems including performance analysis, WAN/LAN / Security vulnerabilities and equipment malfunctions
• Utilize network monitoring tools to diagnose faults and to analyze performance.
• Work with infrastructure, cloud and application teams to design network solutions to meet the needs for different projects
• Provide physical network support if required by traveling to various local offices
• Interfaces with clients, vendors, and other teams on multi-faceted projects involving voice and data requirements in support of enterprise technologies
• Manages assigned global network projects and meets deadlines
• Leads large projects and assigns tasks to supporting Network Engineers and other technical teams
• Independently develop reference materials (network diagrams, installation documentation, etc.) for supported network technologies to be used for both online and in-person training of other technical.
• Serves as both a professional and technical mentor to other Network Engineers
• Proactively identifies areas of improvement (process or technical) and develops plans for associated changes required.
  

• Bachelor's degree in a Computer Sciences or equivalent is required
• 15 years of Technical Network delivery experience of Enterprise Corporate level platforms and projects in global companies
• 15 years' experience in computer electronics and/or telecommunications
• Licensure, certification, and/or registration: Cisco CCNA, Cisco CCNP, Cisco CCDP Checkpoint CCSE CWNP CWSP CWNP CWAP ISC2 SSCP Avaya ACS
• Experience with Aruba wireless
• Previous experience in delivering large platforms on a public cloud (Azure/AWS/GCP) • Established relationship with key public cloud vendors.
• Previous experience leading large IT teams globally.
• Experience in working in a matrix managed organization.
• Strong pharma related IT compliance and risk management experience
• Excellent relationship-building skills, communication skills and team-based project experience. • Excellent English written and verbal communication skills at a senior level both internally and externally.
• Able to engage and mange up, down and across the IT and business without formal authority. • Able to handle crisis situations, develop and execute a response plan.
• Strong IT vendor management skills.
  

Sr. Director – IT Strategy, PMO, Ops Excellence & GBS IT

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Accountable to support all activities related to Regulatory Life Cycle Management activities in Worldwide Markets (EU, US, Other Markets: CMC Variations, Renewals, PSUR, RMP, safety variations etc)
• Hiring, Training and Retention of Staff in the team
• Work closely with Worldwide markets, assesses dossier suitability and creates a submission tracker for all assigned products to ensure appropriate planning and prioritization.
• Work closely with global regulatory teams in the EU/US/Other International Markets to support Life Cycle Management activities within Regulatory Affairs
• Coordinate responses to Health Authorities, with appropriate personnel and departments to resolve outstanding regulatory issues.
• Ensure that cross-functional activities to support submissions and works collaboratively with Market RA to ensure all requirements are met and dossiers are submitted as per the submission plan.
• Establish vision for the team, team building activities, planning and prioritization of daily work and regular business updates to management.

• B. Pharmacy/M. Pharmacy/MSc/Ph.Din Biology/Chemistry
• Experience: 12 to 15 years in RA
• Expertise in global regulatory strategies and life cycle management activities for Worldwide Markets
• Ability to work proactively and independently in a global environment
• Ability to plan, organize and execute projects as required within Global Regulatory Affairs
• Strong Leadership Experience with ability to build a collaborative environment within the team with positive work culture and develop junior staff members.

• Good leadership, project management and communication skills
• Excellent analytical, problem-solving, and self-learning skills.
• Ability to work independently and effectively in a cross-functional team environment;manage multiple projects simultaneously.
• Detail-oriented with a high level of accuracy in work deliverables.
• Strong organizational and time management skills.
• Excellent spoken and written English is essential.