Sr. Manager, Product Quality Owner.

Job content

Janssen Pharmaceutical, a member of Johnson & Johnson’s Family of Companies, is recruiting for aSr. Manager, Product Quality Management, Quality Owner.

The position should be based at the following sites: Allschwil 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 Senior 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 API 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/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 Stability SME’s to gather inputs and handles regulatory questions related to stability
• Ensures standard Global Quality processes are used across sites and facilitates communication
• Leads the preparation of the Pro-active Product Quality Scans.
• Supports Quality-by-Design and knowledge management by approving criticality analysis documents.
• Participates in product safety management teams to present Product Quality Complaints trends and topics. Ensures complaints are well handled, issues are understood, and complaint trends are understood and addressed as necessary.
• Reviews and approves changes to API and Drug Product specifications to ensure the changes cover all quality aspects and are aligned end-to-end.
• Acts as a 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 in one of the following: Pharmacy, Analytical Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree
• A Master’s degree or advanced is desirable.
• A minimum of 5 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 and knowledge related policies, standards and guidance is required.
• Knowledge of Sterile Manufacturing practices is required
• Experience with large molecules (mAbs) is an additional asset.
• Proven 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 API and Drug Product stability is a plus.
• Experience with Quality content of Regulatory filings: questions and responses and with regulatory inspections and preparedness 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.
• 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 constantly evolving? Is career growth and opportunity appealing to you? Apply to this opportunity today.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location

Switzerland-Allschwil--

Organization

Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)

Job Function

Quality

Requisition ID

2105991744W