Manager, External Quality

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Job Description:

We are searching for the best talent for a Manager External Quality to be based in Holly Springs NC.

Purpose: In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region ensuring consistent delivery of pharmaceutical drug substance that meets or exceeds safety regulatory compliance and product standards. The position works closely with External Manufacturing Quality and Compliance functions Internal J&J sites Product Quality Management and Global Manufacturing Science and Technology.

You will be responsible for:

• Ensuring effective and compliant execution of quality systems at external manufacturing (EM) sites.
• Building relationships with internal and external partners with emphasis on Operational Excellence Trust & Transparency Agility & Resiliency Partnership and Innovation.
• Preparing EMs for successful health authority inspections; identifying regulatory compliance risks and following up on associated commitments.
• Providing oversight for technology transfer and new product introduction activities; leading PAI readiness and support associated health authority filings and approvals.
• Participating in the onboarding qualification and ongoing monitoring of external partners.
• Partnering with manufacturing sites and quality counterparts to identify and resolve quality issues and complaints including development of robust CAPA plans and effectiveness checks.
• Reviewing and approving product disposition manufacturing instructions change controls specifications validation documentation and technical studies.
• Contributing to process mapping of key quality systems to identify and implement innovative ways of working.
• Monitoring quality performance through tracking of key performance indicators.
• Partnering with key internal stakeholders in support of supply chain to meet patient supply requirements.
• Assessing current quality systems and recommending improvements to improve compliance and optimize processes.

Qualifications/Requirements:

• A minimum of a Bachelors or equivalent University Degree is required with a focus in engineering science or an equivalent technical discipline preferred.
• A minimum of 8 years working in QA and/or QC functions in pharmaceutical industry.
• Experience in biotherapeutic manufacturing.
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
• Experience with manufacturing-facing support of clinical or commercial manufacturing operations.
• Ability to work independently in support of a portfolio of products and suppliers.
• Ability to quickly process complex information and make critical decisions with limited information.
• Strong interpersonal communication influencing and leadership skills demonstrating an ability to communicate at all levels of the organization.
• Experience with cell culture biotherapeutic drug substance manufacturingpreferred.
• Experience working with external manufacturerspreferred.
• Experience developing or reviewing electronic batch recordspreferred.
• Experience in development or application of digitally-integrated quality metricspreferred.
• This full time role is located in Holly Springs North Carolina.
• The position is remote-hybrid with an expectation of 3 days in-office at manufacturing site in Holly Springs North Carolina and up to 2 days remote work per week.
• May require up to 10% domestic travel.

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 & 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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