Vice President, External Quality, Innovative Medicine (USA)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all the postings we recommend focusing on the specific country(s) that align with your preferred location(s).

• Belgium (Beerse) Req #: R-047878
• USA (New Brunswick Raritan Titusville Horsham) Req #: R-048279
• Switzerland (Schaffhausen) Req #: R-048282
• Ireland (Cork) Req #: R-047878

J&J Innovative Medicine Supply Chain (IMSC) safely and efficiently manufactures high quality (bio) medicines for global markets. We serve the pharmaceutical companies Johnson & Johnson as a center of excellence for pharmaceutical and biologic manufacturing. The IMSC governs supply chain organizations with a focus on flawless execution continuous improvement and valuing our employees to support IMSC vision of Transforming Our World: Delivering affordable medicines to anyone anywhere any day.

POSITION SUMMARY

This leader will provide Quality Assurance Compliance and Technical Support for Global Suppliers Global External Manufacturers (Commercial/Clinical) External Contract Laboratories and hospitals and Cryo-preservation Centers. Provides leadership in the selection development monitoring management and de-selection of External suppliers/manufacturers/contract labs in all regions. Provides QA support for technology transfer and improvement of existing manufacturing processes. Contributes 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. Escalates issues as appropriate to Senior Management and supports the Executive Management Reviews. Works closely with Partnership & External Supply (PES) DPDS Procurement Product Management Customer Management Internal Manufacturing and other Quality Assurance functions within IMSC.

KEY RESPONSIBILITIES

• 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.

OTHER DUTIES

• 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
• Must ensure the Quality Policy and objectives are understood and implemented at all levels of their organization
• Report on performance of Quality System
• Verify that management reviews including a review of the suitability adequacy and effectiveness of the quality system are being conducted
• Ensure resources are in place to allow achievement of the quality objectives

QUALIFICATIONS

Required Minimum Education:

• BA/BS degree required MA/MS/MBA or advanced degree desirable

Required Experience:

• 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 cGMPs 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

Required Knowledge Skills and Abilities:

• 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
• Refined skills in the following Leadership Imperatives: Integrity and Credo-based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency; Prudent Risk-taking; Self-awareness and Adaptability; Results and Performance Driven
• Domestic and international travel: 30-40%

Preferred Experience:

• Experience investigating customer Product Quality Complaints

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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