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Senior Manager, Product Quality Owner, Pqm
il y a 2 semaines
**O **b **j **e **c **t **iv **es **and **R **espons **i **b **ili **t **i **es**
Has end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products.
**M **a **in **Duties / Additional Duties / Sphere of Authority**
Principal Duties:
Compliance with the GMP, EHS and SOX requirements and guidelines, as applicable. Serves as the single point of Global Quality contact for an assigned group of marketed products with medium to high complexity. Responsible for ensuring end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release. The Quality Owner (QO) knows the product history and understands the processes across the various manufacturing sites. The QO establishes and maintains site Quality contacts and drives communication with all Q&C stakeholders. Assures Quality milestones and Quality deliverables are achieved and approves content of spec changes to ensure spec changes are aligned end-to-end. Assure multisite/global/high level product CAPAs and change controls to ensure they are approved and closed appropriately.
Represents Global Quality on the Value Stream Teams (VST). Maintains the flow of communications between Global Quality and VST teams. Brings Quality issues to the VST and assists with prioritization of projects and with key product decisions. Supports the business continuity process including VST strategy and BCP projects. Reviews Proactive Product Quality Scans with the VST and assures appropriate mitigating actions are defined there. Prepares quality sections of Product Strategy and End-to-end Value Stream Mapping. Participates in the F2F VST meetings on PSR and VSM finalization and project prioritization. Aligns and interfaces the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
Accountable for all stability related activities of commercialized products including change management study management. Liaises with Product data specialists or Product quality specialists to gather input on stability topics (e.g. draft stability protocols and reports).
Collaborates with a Product Quality Specialist on regulatory questions related to stability and on preparation of regulatory PA inspections regarding stability topics.
Manages changes of shelf life / retest period and storage instruction.
Defines and oversees the necessary QA resources for global and local Q of his or her assigned products.
Leads a comprehensive Quality Sub team that assures Quality throughout, DS, DP, Fill Finish
& Device:
- Assures product quality over the life cycle, understands the performance, and risk profile, throughout shelf-life
- Ensures patients get the right quality products.
- Supports the sites, represents the sites on VS Team.
- Supports QA communication/issue resolution with External Manufacturers and
- Business Partners, as applicable.
Ensures standard Global Quality processes (risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality
- Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
- Supports preparation of the criticality analysis per schedule.
- Ensures complaints are well managed, issues are understood, and trends in Global Medical Safety, GMS are understood and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
- Coordinates and/or owner of complaints trend signal investigations.
- Partners with Quality Integrator to complete Transfer of Ownership activities.
- API, RM, FP specifications change approvals.
Presents project updates to QM for Global Quality alignment
- Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions. Participates and actively engages on IMTs. Supports field/recalls as needed.
Review/approval/support regulatory filings and answering questions from the agency during filing review.
Support agency audits for the product assigned.
- Demonstrate basic knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
**Decision **making and Problem Solving**:
- Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
- Gives input to the development of new strategies and implements and deploys strategies.
- Aids in the creation of product portfolio guidelines on the control strategy for commercial
products which will influence the life cycle management strategy and the total quality cost during commercial production.
- Provides Quality structure, direction and decision making to the teams (Quality and VST) in situations of medium risk, uncertainty and ambigui
