Sr. Manager, Product Quality Owner

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting

**for a **Sr. Manager, Product Quality Management, Quality Owner.**:
The position should be based at the following sites:

- Beerse, Belgium,
- Leiden, The Netherlands,
- Cork, Ireland
- Malvern, Springhouse, Chesterbrook, USA
- Schaffhausen in Switzerland.

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 Manager, Product Quality Management, Quality Owner has end-to-end accountability for the quality strategy and quality aspects for an assigned portfolio of commercial products.

**Main responsibilities include but are not limited to**:

- Ensures end-to-end Quality for assigned products across Drug Substance manufacturing site(s), Drug Product manufacturing/packaging site(s), and QC testing and release sites.
- Represents Global Quality on the Value Chain Teams (VCT). Prepares quality sections of Product Strategy and End-to-End Value Stream Mapping for the development of Product Strategy Roadmaps and project prioritization.
- Leads comprehensive Quality Subteams that assure end-to-end quality throughout Drug Substance, Drug Product, Fill Finish & Medical Devices (if applicable):

- Assures product quality over the life cycle, understands the product quality performance and risk profiles throughout shelf-life of the product.
- Supports QA communication and issue resolution with internal and external manufacturers and business partners, as applicable.
- Works with the cross-functional/site teams to escalate product quality issues. Participates and actively engages on Issue Management Teams to mitigate the issues.
- Is Accountable for all stability-related activities of commercialized products including change management and study management.
- Liaises with PQM Quality SME’s to gather input on stability topics and handles regulatory questions related to stability
- Ensures standard Global Quality processes are used across sites and facilitates communication
- Manages preparation of the Pro-active Product Quality Scans.
- Supports preparation of the criticality analysis per schedule.
- Participates in product safety management teams to present Product Quality Complaints trends and topics. Ensures complaints are well managed, issues are understood, and complaint trends are understood and addressed as necessary.
- Reviews and approves changes to Drug Substance and Drug Product specifications to ensure the changes cover all quality aspects and are aligned end-to-end.
- Acts as Quality reviewer of post-approval health authority submissions. Reviews and approves responses to questions from health authorities. Supports agency audits for the assigned products

**Qualifications**
- A minimum of a Bachelor’s degree is required with a major or concentration in one of the following: Pharmacy, Analytical Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree.
- A Master’s degree is desirable.
- A minimum of 7 years’ experience in the pharmaceutical industry is required. In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies is required.
- In-depth knowledge in cGMP standards, policies, and procedures is required.
- Knowledge of Aseptic Manufacturing Practices is required
- Experience with Large molecules (mAbs) manufacturing processes and Bioassay Analytical Method Validation is an additional asset
- Consistent track record in leading multifunctional ‘virtual’ teams.
- Demonstrated ability to be a strong change facilitator to drive a team towards decisions in an environment with medium levels of ambiguity, complexity and risk.
- Experience in Drug Substance and Drug Product stability is a plus.
- Experience with Quality content of Regulatory filings: questions and responses is preferred.
- Relationship building, partnering and influencing in an international, virtual matrix organization. Negotiation, communication and presentation skills across all levels are important.
- Ability to quickly assimilate new technologies, perform risk assessment and develop action plans.
- Understands the business implications regarding quality positions and decisions.
- Proven experience in driving creative solutions and analytical/problem solving skills.
- Fluency in English is a must.
- This position may require up to 10% domestic and international travel as business demands.

Do you strive to join an outstanding team that is dynamic and ever-changing?

**Johnson & Johnson Family of Companies are equal opportunity employers, an