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.
