Vice President, External Quality, Innovative Medicine
Johnson & Johnson
full-time
Posted on:
Location Type: Office
Location: Horsham • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $199,000 - $366,850 per year
Job Level
Lead
About the role
- Provide Quality Assurance, Compliance and Technical Support for Global Suppliers, Global External Manufacturers (Commercial/Clinical), External Contract Laboratories and hospitals and Cryo-preservation Centers
- Provide leadership in the selection, development, monitoring, management, and de-selection of External suppliers/manufacturers/contract labs in all regions
- Provide QA support for technology transfer and improvement of existing manufacturing processes
- Contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products
- Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required
- Escalate issues as appropriate to Senior Management and support the Executive Management Reviews
- Work closely with Partnership & External Supply (PES), DPDS, Procurement, Product Management, Customer Management, Internal Manufacturing, and other Quality Assurance functions within IMSC
- Develop, implement, and review of SOPs for interactions with External partners
- Investigate customer product quality complaints
- Apply cGMP regulations and other Health Authority and international requirements to all aspects of the position
- Coordinate change control documentation and approval process for Global External Supply Chain partners and provide the proper interface to Partnerships & External Supply (PES) and Innovative Medicine Supply Chain (IMSC) Internal Manufacturing
- Act as senior level interface to key Health Authorities in all regions for all IMSC External suppliers/manufacturers, contract labs and Hospitals/cyro-centers
- Interface with the Product Management and Customer Management teams to supply the markets
- Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time
- Monitor trends, identify issues, recommend and implement appropriate actions
- Develop Strategy for the successful attainment of Sector and Corporate strategy
- Travel to External sites to provide cGMP assistance and quality direction
- Provide cGMP compliance support to External suppliers/manufacturers and contract labs by investigating and resolving quality issues
- Provide Quality oversight and participate on technical transfer teams
- Ensure that an adequate and effective quality system has been established and maintained
- Has the authority to establish and make changes to the company quality policy
Requirements
- 15+ years of senior level experience in quality management in a pharmaceutical and/or biotechnology environment
- Drugs, biologics and medical devices are essential to success
- External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development
- Presenting issues to all levels of the organization
- Working with Regulatory authorities
- Knowledge cGMP’s and other applicable Global FDA, EMEA, AP, regulations
- Experience managing large and complex organizations including a network of sites
- Demonstrated expertise in maintaining strong compliance profile
- 10+ years as a seasoned people manager with proven track record of leading large global matrixed teams
- Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers
Benefits
- Health insurance
- 401(k)
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceComplianceTechnical SupportcGMP regulationsQuality System DevelopmentTechnology TransfersQuality Event ManagementData AnalysisAuditingChange Control Documentation
Soft skills
LeadershipCommunicationProblem SolvingInterpersonal SkillsStrategic DevelopmentTeam ManagementCollaborationTrend MonitoringIssue EscalationCustomer Management