Sr Mgr Quality Assurance

Key Responsibilities

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

• 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
• 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
• 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.
•  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
• Training
  • 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.
• 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

Qualification & Requirements

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

Benefits

No information available.