Johnson & Johnson Careers
Senior Manager ESIQ DPDS
Requisition ID: 1905758071W
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Chain, LLC, is part of the Janssen Pharmaceutical Companies.
Senior Manager ESIQ DPDS
Is responsible for the introduction of New Products at external partners and will drive the quality activities from first in human studies till clinical phase 3.
Drives Quality Assurance, Compliance and Technical Support for external manufacturers used for the manufacturing of Investigational Medicinal products including the Actelion portfolio.
Drives the transfer process in late phase development to the JSC organization.
Provides leadership in the selection, qualification, monitoring and management of External Manufacturers in EMEA.
Contributes to the overall development, implementation and execution of quality systems in support of the external manufacturers.
Provides leadership to a team of Quality professionals and business partners.
Provides strategic direction from a Quality and Compliance point of view for the management of external manufacturers.
Leads or serves in teams or major cross-functional project initiatives.
Acts as a coach and mentor for other Managers and Associates in External Supply Integration Quality and DPDS.
- Provide cGMP direction to contract manufacturers by pro-active management of quality using risk-based approaches.
- Drive phase appropriate GMP implementation at external manufacturers in early and late phase development to fulfill the business requirements.
- Collaborate with business partners globally and align with the DPDS strategy.
- Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.
- Monitor trends, identify issues, recommend and implement appropriate actions.
- Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
- Lead the qualification of External Manufacturers and provide quality input during the selection process as a team member.
- Show leadership during regulatory inspections at EM’s and provides follow up on regulatory commitments.
- Develop, implement, and review of SOPs for interactions with External Manufacturers.
- Investigate customer product quality complaints.
- Apply cGMP regulations and other FDA/EMEA and international requirements to all aspects of the position.
- Coordinate change control documentation and approval process at EM.
- Drives the transfer process in late phase development to the JSC organization.
- Interface with other functions (DPDS, JJSA, Technical Operations, CSC, QA-CSC, PQM, etc.) in support of External Manufacturing.
Bachelor’s Degree with a minimum of 10 years in a GMP regulated environment is required; preferably in a pharmaceutical / biologics manufacturing or quality environment.
Advanced degrees are a plus and may reduce the experience required.
Extensive knowledge of Quality Assurance, Quality Control and Compliance.
Significant experience in the development, implementation of quality systems and interactions with contract manufacturers is preferred.
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)