Quality Specialist Iii jobs at Teva in India, Bengaluru

• Develop and execute global product strategies, including launch planning, lifecycle planning, and indication and geographic sequencing in line with the IDP
• Align global forecasts, TPPs, and clinical endpoints to ensure strategic coherence
• Translate clinical and scientific data into compelling value propositions and messaging in partnership with the Global Pricing, Value & Access team
• Responsible for global brand strategy efforts, including core global campaign and content delivery
• Lead the annual brand planning process (3 year time horizon), ensuring clarity and consistency across regions for key global brands
• Partner cross-functionally with Regional Commercial Teams, R&D, Medical Affairs and Business Development to prepare for, and guide portfolio decisions and evidence generation through stage gates and governance.
• Support BD evaluations with strategic fit assessments and commercial opportunity framing in line with the Neurology Disease Strategy.
• Drive global launch readiness and market expansion, collaborating with regional and affiliate teams, identifying market opportunities including geographies and indications
• Collaborate on supply chain strategies to optimize profitability, CoGs and returns
• Oversee and direct market insights work, competitive intelligence, and performance tracking (KPIs) to inform strategy
• Engage with KOLs, advocacy groups, and external stakeholders to shape brand perception
• Build and lead a high-performing global team and cross functional partners, fostering innovation and accountability with a strong “outside in” perspective
• Demonstrated outstanding storytelling and leadership engagement under pressure.
• Ability to navigate ambiguity and drive alignment across global and regional stakeholders
• Strategic Global Commercial leadership for assets outside of the Immunology and Neuro portfolio e.g rare disease.

• Bachelor’s degree required; Master’s degree or other advanced degree a plus.
• 20+ years experience as a commercial leader with exceptional track record of delivering at scale with proven results and leadership impact
• Significant Commercial Leadership role, with a large span of control; P&L accountability (e.g GM or Business Unit Head or Head of Sales and Marketing Division) within the last 5 years
• Experience with US Market and/or large market (e.g. EU 5) experience required
• Experience working across multiple therapeutic areas - Neuroscience preferred

• Experience in a global role, and understanding the relationship between global functions, and the markets.

Skills/Knowledge/Abilities:

• Deep understanding of the neurology market
• Ability to positively influence cross-functional enterprise stakeholders at all levels of the organization
• Demonstrated consistent success in building and developing high-performing teams across regions
• Recognized as an enterprise commercial leader by the business inside and outside of Teva

• Performs broad range of work and complex activities with substantial autonomy
• Sought out by others for guidance
• Leads and develops others

TRAVEL REQUIREMENTS:Approximately up to 30% travel to support key meetings and cross-functional planning

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.

SVP Global Product Strategy- Innovation Medicines

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 incumbent will perform development in SQL Server, Data Bricks and other related applications. The Application Developer will also deliver, and/or support the delivery of, projects/initiatives related to the Value and Access domain, resolve operational issues, ensure the application’s integrity and availability to sustain day to day operations with a focus on the application’s interfaces and integrations.

• Technical Delivery: Serve as the Technical and Subject Matter Expert responsible for solutions delivery and support of Value and Access solutions and systems interfaces. Lead technical design and requirements gathering. Develop technical documents and provide architectural recommendations and design guidance across Value and Access solutions and technologies, ensuring solutions are sustainable and meet technical standards. Design and develop high quality and scalable application code using REACT UI, SQL, PL/SQL, Python, Unix shell scripting, etc.
• Develop Business Relationships: Create effective relationships with business stakeholders to ensure expectation management and alignment of team priorities with the business.• IT Improvement and Innovation: As an IT individual contributor, the incumbent is expected to contribute independent ideas, proposals, and projects for improving the efficiency, effectiveness, and value of IT at Teva.
• Sustain Operations: Support the business stakeholders in their day-to-day operations providing the highest levels of service and maintaining a stable operating environment. Coordinate with infrastructure, IT Security and other internal, IT support functions to maintain system stability while minimizing business impact of routine and non-routine IT maintenance activities. Work to resolve issues and ensure the application’s integrity and availability to sustain day to day operations with a focus on the application’s interfaces.
• Follow Teva Safety, Health, and Environmental policies and procedures.
• Other projects and duties as required / assigned

• Must have a bachelor’s degree in computer science or a related filed
• 7+ years’ experience working as a backend or full stack developer with experience in SQL Server, Databricks or React UI
• Experience with IT in Pharma preferred.
• Proficiency in SQL Scripting and experience with complex queries, stored procedures and performance optimization techniques.
• Experience working with commercial pharmaceutical data (IQVIA, MMIT, Fingertip, Medicaid, Patient Data, etc.)
• Experience working in global cross functional teams preferred
• Strong understanding of data warehousing concepts, data modeling and database design principles
• Must possess Strong analytical and problem-solving skills
• Must have strong experience supporting complex, multi-system, end-to-end integrations in a dynamic production environment with ability to troubleshoot across systems.
• Must possess good communication skills and be able to convey technical concepts to a non-technical audience.

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.

• Perform initial problem determination (level 1) in support of scope of services with related hardware, software and services support.
• Provide in-scope technical advice and guidance, trouble shoot end users queries / issues and advise potential resolutions within specified KPIs and metrics.
• Handle service entitlement failures associated with requests for in-scope services.
• Assign records to other support groups, as and when required.
• Act as service desk's advocate when dealing with other support / resolver groups.
• Initiate the service outage procedure, update VRU status messages with outage information, as required.
• Process requests for password resets and manage the requests to satisfactory completion.
• Accurately log all interactions via established business processes and tools.
• Understand and contribute to the improvement of various performance metrics.
• Update inventory for software licenses, hardware and reporting.

• 1 -2 years' experience as a technical service desk agent
• Excellent logical reasoning, troubleshooting and problem determination skills
• Strong communication (verbal and written) skills
• Knowledge and experience with Remote takeover tools.
• Work in office is required (No work from home option)

First Line Manager

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.

• 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.

• Technical/functional knowledge in Accounting and fixed asset closing area
• Ensure that capitalization, maintenance, depreciation, amortization are properly recorded and analyzed
• Very well verse with lease accounting concept
• Preparation of Journal Entries, Supporting schedule & Roll forwards
• Perform monthly and quarterly FA closing activities of multiple entities
• Analysis of the various fixed asset accounts and variances per legal entities, obtain explanation on deviations and prepare a summarized reporting on a monthly basis within scheduled time
• Preparation & clearance of open reconciling item in account reconciliations
• Hands on experience in submission of trial balance in HFM
• Identify & drive standardization opportunities in processes and tasks across the team
• Acting as a key contact for local teams for fixed assets and lease related questions
• Ensuring that accounting books and records comply with accounting policies and regulations
• Provide supporting documents and explanations for all internal and external audit as and when required
• Participate in ad-hoc activities and projects

• University education in Accounting or Finance required
• Minimum experience of 3+ years into managing fixed assets & leases register for large scale organization
• Preferably familiar with US GAAP
• Working knowledge of internal controls
• Good working knowledge of SAP
• Good understanding of accounting processes and can follow accounting policies
• Good analytical skills and have hands on experience in Fixed asset as well as Leases process
• Fluent verbal and written communication in English
• Experience in a multinational firm or within a GBS (Global Business Services) is preferred
• Hands-on and proactive; strong organizational skills
• Accustomed to working with deadlines, in a dynamic environment
• Results driven and service oriented to internal and external customers
• Excellent collaboration with colleagues within the local organization and with the colleagues of the global business service to support the overall Finance department’s goals and objectives
• Flexible and able to work in a changing environment
• Strong focus on improvement opportunities
• Want to work in a new (to be) established team
• Process documentations and certifications – will have to ensure that all process are appropriately documented and periodically certified by team members on regular basis

Group Leader Financial Operations

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.

• Bachelors in Computer Science or related degree
• 5 to 10 years Relevant ServiceNow developer experience
• Business Communication and strong knowledge on SDLC process
• Good control on ServiceNow core development concepts:
• Strong ServiceNow base structure knowledge (table dictionary. etc.)
• Update sets
• Client side and Server-Side scripts and associated concepts. Strong knowledge on scripting.
• Good control in integration concepts
• Having good knowledge on Automation activities.
• Strong knowledge on service catalogs workflows flow designer and automating flows.
• Service Portal Knowledge (Agent workspace is optional but preferable)
• Implementation knowledge on ITSM and NON ITSM modules. (Non ITSM modules includes HRSM, CSM, GRC, Facility…etc.).