Sr Manager Product Quality Integrator

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: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA or Chesterbrook, PA

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

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-ended 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 partners.
- Assures Quality achievements and Quality stage gate deliverables are achieved.
- Quality reviewer of health authority (HA) 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.
- Leads a comprehensive Quality Sub team that assures Quality throughout clinical development:

- Assures product quality development through Launch and Grow stage.
- Supports the sites, represents the sites on CMC and Value Chain Teams (VCT).
- 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.
- Leads 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 handled, issues are understood, and addressed as vital. 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.
- 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.
- Presents project updates to quality management for Global Quality alignment.
- Advance issues when appropriate. Works with the cross functional/site teams to co
- ordinate and hold Critical issue meetings, minutes archival, follow up on actions.
- Participates and actively engages on Issue Management Teams (IMTs). Supports field actions/recalls as needed.
- Drives Decision making and Problem Solving:

- Drives/coordinates decisions on behalf of Global Quality.
- Gives input to the development and deployment of new 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 and time to market.
- Provides Quality structure, direction and decision making to the teams (Quality, CMC and VCT) 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.

**Qualifications** Education**:

- A minimum of a bachelor’s degree is required with a major or concentration in one of the following: Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree concentration.
- A Master’s degree or advanced (pharmaceutical, chemical background, biological vital or a similar degree concentration) is preferred

**Required Skills**:

- A minimum of 8 years’ experience in a highly regulated industry is r