Manager, External Quality
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Holly Springs • North Carolina • Pennsylvania • United States
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About the role
- Providing quality leadership and oversight of external manufacturers in the North America region.
- 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.
Requirements
- A minimum of a Bachelor’s 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 manufacturing preferred.
- Experience working with external manufacturers preferred.
- Experience developing or reviewing electronic batch records preferred.
- Experience in development or application of digitally-integrated quality metrics preferred.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancequality controlGood Manufacturing Practicesbiotherapeutic manufacturingcell cultureelectronic batch recordsquality metricstechnology transfernew product introductionCAPA plans
Soft Skills
leadershipcommunicationinterpersonal skillsinfluencingcritical decision makingindependent workrelationship buildingproblem solvingorganizational skillsagility