דרושים Sr Dir R&d Department ב-טבע ב-הודו

• 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.

Responsible for planning, designing & implementing best-in-class technical/engineering practices and solutions required in plant utilities at various sites located across world.

Provide expert guidance and support to site /global colleagues to ensure that latest industry trends, technologies, and best practices are in place. Plan and lead the global programs required to enhance site team capabilities in the field of plant utilities and energy management.

Responsible to ensures safe, reliable, and cost-efficient plant utilities to support production and facility operations, while complying with environmental, health, and safety regulations. Develop and maintain engineering standards /guidelines and procedures to ensure compliance with regulatory requirements and industry expectations.

• Should be able to act as the global SME for plant utilities and energy management in the pharmaceutical industry (sterile and non-sterile)
• Should be able to plan, design and prepare the deliverables independently required in different project phases like feasibility studies, conceptual design, Front-End Engineering Design (FEED) and detail design related to plant utility systems.
• Should have strong knowledge about greenfield and brownfield projects from inception till execution including validation /commissioning including strong troubleshooting and problem-solving abilities.
• Should have excellent knowledge on key topics like steam boilers, condensate recovery systems, compressed air, nitrogen, process gases, cooling and heating utilities, etc.
• Should have good understanding knowledge on international codes and standards like ASHRAE, ASTM, ISO, ISPE etc.
• Responsible to prepare, develop, review and publish internal company Standards, Datasheets/URS, best practices, guidelines in line with the national/international and applicable local guidelines.
• Should be able to perform technical assessments based on the standards, guidelines, local laws, industrially accepted practices etc and prepare its remediation plan.
• Should have good knowledge in testing and commissioning of utility systems including FAT and SAT and provide required technical expertise needed to resolve issues (troubleshooting).
• Should be able to lead/organize independently the utility program like community of practice, publishing newsletters, knowledge sharing sessions, trainings and vendor presentations.
• Should have good knowledge on CapEx and OpEx related cost estimations.
• Capable to select/propose solutions and alternatives with proper justification
• Proficient to prepare project execution strategy, schedule/timeline and monitor the progress as per the schedule.
• Should have skilled to address the deviations (if any) and follow the escalation matrix to report the critical deviation/observations/milestones to the management.
• Capable of adhering to the strict deadlines set by the global team, global business partners and project managers.
• Actively support the utility projects, upgrades, and new installations planned at different sites located across world.
• Able to act as global project / program manager to monitor engineering projects related to plant utilities

Energy Management
• Strong knowledge of energy efficiency and emission reduction best practices.
• Capable to evaluate, plan and implement energy efficient solutions/technologies in all utility areas.
• Expertise in supply vs. demand analysis, measurement of utilities including efficiency trials as per applicable standards/codes like BS 845 Part 1, PTC 4.1 etc.
• Able to perform technical evaluation of proposals and define opportunity areas.
• Ability to identify opportunities to improve energy efficiency, reduce emissions and operating costs.
• Guide / support team to develop technically sound solutions to reduce utility consumption / operating costs / CO2 emissions and improve the life of assets in compliance with the required guidelines and codes.
• Able to integrate into the utility planning / design with focus on energy efficiency, waste reduction, and environmentally friendly solutions.
• Ability to understand and guide team to develop/ monitor required KPIs to meet sustainability and energy management goals.
• Translate ISO standards requirements into practical actions and specifically ISO 50001

• Bachelors/master’s degree in chemical / mechanical engineering
• 15+ years of experience in design, engineering, consulting, construction and in commissioning of plant/black utilities in the Pharma / chemical Industry.
• Working experience in manufacturing, consulting is preferred
• Energy Efficiency Auditor Certification
• Good Knowledge of ISO 50001:2018 is preferred

• Process Optimization: Facilitate VSM/Kaizen events, streamline processes to eliminate waste, improve efficiency, and enhance overall performance. Drive Continuous Improvement projects at org level
• Collaborate with Functional teams to drive automations/BOTs
• Initiate, Drive NPS/PSQI Surveys and actions to improve the engagement scores/Customer experience
• Performance Metrics: Define and monitor performance metrics. Develop metrics that are relevant and measurable on a global scale, considering variations in business needs, customer expectations, and regional priorities
• Best Practices Sharing: Facilitate the sharing of best practices. Establish mechanisms for sharing successful Lean practices and lessons learned across diverse regions within the organization
• Initiate & drive several Lean Six Sigma practices to encourage people participation in continuous improvement, build OpEx mindset in HRSS, thus improving the lean maturity of the HRSS teams
• Develop and drive a global CI roadmap for HR Shared Services aligned with enterprise goals
• Manage and execute complex, cross-regional CI projects using Lean, Six Sigma, and Agile methodologies
• Identify gaps and inefficiencies across key HR processes (e.g., onboarding, payroll, employee data, case management), and implement scalable solutions
• Promote CI mindset and practices across teams through coaching, training, and change enablement
• Leverage KPIs, VOC, and analytics to diagnose root causes, measure impact, and continuously monitor improvements
• Stakeholder Engagement: Partner with HR leaders, IT, Compliance, and regional teams to align priorities and ensure adoption of solutions
• Governance & Reporting: Establish governance mechanisms to track project benefits, milestones, and risk mitigations

• 10+ years of experience in HR Shared Services or Global Business Services field HR, with at least 5 years in CI or Operational Excellence roles
• University education in Finance/Science/Engineering is required
• Certified Lean Six Sigma Black Belt/Lean Expert and practical application knowledge
• Preferred Project Management Professional (PMP) certification
• Influencing and negotiation skills - Ability to get the work done with different level of stakeholders
• Fluent verbal and written communication in English
• Experience in a multinational firm or within GBS (Global Business Services) is preferred
• Hands-on and proactive; strong organizational skills
• Global mindset and ability to work across cultures and time zones
• Passion for continuous improvement, innovation, and employee experience
• Hands-on leadership style with a bias for action and outcomes
• Excellent analytical, facilitation, and communication skill
• Demonstrated ability to drive stakeholder alignment, influence leadership, and manage change in a matrixed environment

Head of HR Process Excellence

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 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

• Maintain the list of Instruments/ equipment’s
• To prepare and implement calibration and preventive maintenance schedule of Instruments/ Equipment.
• To take facility round and ensure all Instruments/ equipment’s are working normally.
• To check the calibration records and its proper documentation.
• Prepare/revise the Instruments/Equipment’s related SOP’s.
• Handle SAP system to purchase material, service, maintenance contract, asset disposal and invoice processing.
• Co-ordination with all AMC/CMC vendors for timely preventive and breakdown maintenance of Instrument / Equipment’s.
• Co-ordination with finance department for timely payment of all vendors.
• To carry out other responsibilities as and when assigned by HOD or Designee.
• To support EHS department to implement EHS programs and activities as a part of EHS committee members.

• B.E (Instrumentation OR Electrical)
• 2-3 Years of experience in Instrumentation Maintenance

• Manage end-to-end of the Employee Life Cycle Hire to Retire
• Leave and Attendance management, monitoring payroll inputs sent on monthly basis
• Implementation of Global and India HR Policies
• HR Analytics and Reporting, responsible for HR metrics - Headcount report, attrition report, exit analysis, Organization structure, absenteeism etc.
• Managing HR Audits
• Provide support and advice on employee relations matters, managing disciplinary action process
• Day to day grievance handling
• Contribute to the evaluation and development of HR strategy and performance in co-operation with the executive team
• Plan and direct for Training of employee including senior managers, maintain contact with outside resources for training
• Provide coaching to People Managers to hold monthly meaningful conversations with team members to discuss performance, coaching and feedback, training needs, and career discussions and monitor progress
• Base knowedge in managing Union, and should have been participated in Union negotiations
  

MBA / Post Graduate with an HR specialization; 12+ years of experience in an HR Operations Profile