Sr Mgr Quality Assurance

Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

This incumbent

• Acts as first line proxy for Associate. Dir. PQRs Global Quality GBS, India & R&D Quality
• Ensures that the APR/PQR for Teva products and review/approval of R&D Documents 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.
• Defines team operating standards and ensures essential CORP & local procedures are followed based on knowledge of own discipline.
• Manages and supervises a team of < 20 professional employees consisting of authors, reviewers, optional approvers and Group Leaders heading different Quality oversights.
• Is accountable for the performance and results of the team under his/her responsibility within the function Global Quality GBS.
• Creates and adapts departmental plans and priorities to address resource and operational challenges for PQR compilation, review, approval and for review, release of R&D documents.
• Ensures that decisions are guided by CORP policies, procedures and Global Quality´s business plan.
• Receives guidance from Associate Director Global Quality- GBS India and R&D Quality, Sen. Dir.  Quality Strategy and Shared Services and Global Head RD Quality, other Managers in Global Quality GBS and GBS, Global IT, EMSO Quality affiliates, Commercial Quality EU & IM, TGO and R&D Quality
• Provides technical guidance and training to employees, colleagues/related managers and/or TEVA internal customers.
• acts as escalation point within the interaction between the Team and external suppliers or internal stakeholders.
• Participates in Quality councils and delivers input for the performance of the team/teams under his/her responsibility.
• Is responsible for employee performance objectives in the team, conducts performance reviews and recommends pay actions.
• Supports modernization by use of relevant IT Tools.
• Ensures continuous improvement of efficiency and compliance by establishing and monitoring relevant KPIs (OPEX).

How you’ll spend your day

Job responsibilities

A) Approval of PQR’s

The owner of the function

• 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.
• Recommend actions and communicate to internal and external stakeholders for identified actions as part of the Approval process to improve quality of products (CAPA)
• Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues of the team to higher management for non-responsive CMO’s and TEVA’s internal stake holders 

B) Supervisor R&D Quality 

Provide oversight for execution of activities within the R&D Quality Shared Services unit including but not limited to:

• Review/Approval of R&D documents including analytical methods, validation protocols and reports, study protocols and reports, specifications, and executed batch records.
• Release of Materials
• Provision of Inspection Readiness support
• Provision of support for generation and maintenance of QTA’s
• Performance of Corporate Gap Assessments against R&D site SOP’s
• Creation/revision of R&D site SOP’s
• Review/Approval of Equipment/Instrument qualification, calibration, and maintenance documents.
• Review/approval of Computer Systems Validations documents
• Management and trending of R&D Quality kpi’s
• Preparation of presentations for R&D site’s Quality Council meetings
• Data reviews

C) Quality Management Systems

• The owner of the function
• Ensures that the local quality management system is maintained in the team under his/her responsibility
• 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
• Writes or approves local SOP’s and its related templates.
• Monitors self-inspections and related CAPA of the team under his/her responsibility as per timelines and verification of compliance report.

JD to be contd..

D) Performance Management

• Monitors and compiles the KPI scores of the team under his/her responsibility and supports the team to improve their efficiency.
• Participates in the customers council meetings and supports the effectiveness of the councils
• Participates in the Monthly Quality Council of the PQR-Center and enhances the effectiveness and efficiency of it by suitable reports/metrics and continuous improvement.
• Writes or evaluates   the monthly reports as needed by various stakeholders.
• Proactively initiates and leads continuous process improvement projects to improve efficiency groups across the team.

E) Training

The incumbent

• Performs 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.

F) Miscellaneous Support

The owner of the function is responsible for

• Maintaining Employee Central and other relevant Master Data
• Responsible for approval of PO’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
• Write or Review monthly report to be presented to higher management
• Approve various access levels for all reportees for various software on an annual basis
• Monitor HC justification for every approval
• Maintain CAPA reports and Risk Assessments  on the performance of the department in cases those are requested by health authorities
• Support the maintenance of the IC QTA –with current updates
• Ensures the robust handover procedure in case of exits

Your experience and qualifications

• Bachelor’s degree in pharmacy or Natural Sciences, master’s degree in pharmacy or Natural Sciences
• More than 12 years of experience in QA / QC, R&D 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 incl. local Indian Languages
• Very Good communication skills and ability to work in a matrix structure.
• Very good knowledge of Computerised Systems in TEVA´s IT landscape (Trac-Wise, SAP, LIMS, Global Insights, Hot Dog Glorya, Veeva etc.)
• Good understanding of manufacturing, QC, R&D and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Ability to guide a team and influence other stakeholders
• Ability to work as manager in a matrix organization (GBS) and act properly on conflicting interests
• Mobility required

Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.