Senior Manager, Product Quality Management, Quality

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator** The position can be based at one of the following sites: Wayne, PA; Titusville, NJ; Raritan, NJ; Horsham, PA; or Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland;

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Senior Manager, Product Quality, Launch and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization for an assigned group of large molecules (biological) products.

**Key Responsibilities**:

- Represents Global Quality Chemistry, Manufacturing, and Controls (CMC) and Value Chain Team (VCT). Serves as liaison between CMC team, Analytical Development and Product Quality Management. Serves as the single point of Global Quality contact. Drives communication with all Q&C stakeholders.
- Assures Quality milestones and Quality stage gate deliverables are achieved.
- Quality reviewer of health authority submissions (i.e., IND, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product assigned.
- Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
- Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:

- Assures product quality development through Launch and Grow stage.
- Supports the sites, represents the sites on CMC and VC teams.
- Assures patients get the right quality products.
- Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
- Ensures standard Global Quality processes (new product introduction processes, risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality.
- Manages preparation of the iPPQS and 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 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 PQ VO&LS to complete Transfer of Ownership activities.
- API, RM, FP specifications approvals.
- Represents Global Quality on the Value Chain Teams (VCT).
- Maintains the flow of communications between Global Quality and VCT teams.
- Brings Quality issues to the VCT and assists with prioritization of projects and with key product decisions.
- Supports the business continuity process including VCT strategy and BCP projects.
- Reviews Proactive Product Quality Scans with the VCT and assures appropriate mitigating actions are defined there.
- Prepare quality sections of Product Strategy and End-to-end Value Chain Mapping.
- Participate in the F2F VCT meetings on PSR and VCM finalization and project prioritization.
- Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
- Presents project updates to QM for Global Quality alignment.
- Escalate issues when appropriate. Works with the cross functional/site teams to co
- ordinate and hold Escalation meetings, minutes archival, follow up on actions.
- Participates and actively engages on IMTs. Supports field/recalls as needed.
- Drives 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 new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
- Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
- Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of medium risk, uncertainty and ambiguity.
- Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.

**Qualifications**
- A minimum of a Bachelor’s or equivalent University degree is required with a major or concentration in one of the following: Pharmacy, Chemistry, Biology, Biochemistry, Enginee