Johnson & Johnson Careers
Manager, Product Quality Management, Quality Integrator
Requisition ID: 00001DAE
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Product Quality Management, Quality Integrator. The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Geel, Belgium; Schaffhausen, Switzerland; Raritan, NJ; Spring House, PA or Malvern, 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 Manager, Product Quality Management, Quality Integrator 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.
Main responsibilities include but are not limited to:
- Represents Global Quality on the CMC team. Serves as liaison between CMC team, Analytical Development and Product Quality Management. Serves as the single point of Global Quality contact.
- Assures 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.
- Defines and owns the necessary QA resource for global and local QA of his or her assigned products.
- Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
- Ensures standard Global Quality new product introduction processes and norms are used across sites and facilitates communication throughout Global Quality.
- Maintains the flow of communications between Global Quality and the CMC Teams. Drives communication with all Q&C partners.
- Presents project updates to QM for Global Quality alignment in advance of Stage Gates (as required).
- 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 concentration.
- A Master’s degree or advanced is desirable (pharmaceutical, chemical background, biological necessary or a similar degree concentration).
- A minimum of 5 years’ experience in a highly regulated industry is required.
- Experience in the pharmaceutical or biotechnology industry is required.
- In-depth knowledge in cGMP standards, policies and procedures is required.
- Knowledge of Biotech and/or Pharma Manufacturing required, particularly in technology transfer, process development or process validation.
- Consistent track record in leading multifunctional ‘virtual’ teams to success is a plus.
- Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering.
- Experience in Product & Process Development is a plus.
- Experience with Quality Systems is preferred.
- Experience with Quality content of Regulatory filings: questions, and responses is preferred.
- Experience with regulatory inspections and preparedness is preferred.
- Relationship building, partnering and influencing in a 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 skills.
- 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? 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.
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Switzerland-Schaffhausen, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Geel, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-Pennsylvania-Malvern
JANSSEN SUPPLY GROUP, LLC (6046)