External Quality Manager – Manufacturing Support
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Beerse • Belgium
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About the role
- Play a key role in supporting the External Quality EMEA team in the oversight of the External Manufacturers portfolio for Large Molecules
- Focus on quality and compliance activities including batch record review, records management, deviation and CAPA management, and Change Control oversight
- Build and maintain strong working relationships with EQ LM EMEA Site Leads and associates
- Review and approve executed batch manufacturing records provided by External Manufacturers
- Assess External Manufacturers Technical Release Packages for compliance with J&J specifications and Quality Agreements
- Prepare EQ Authorization documentation, including J&J restriction management: Authorize batches for downstream processing in collaboration with EQ Site Leads, downstream site QA, and the External Manufacturers
- Proactively identify risks or delays in batch review and CMO technical release, and drive timely resolution
- Evaluate deviations and associated CAPA plans to ensure effective resolution
- Identify and address issues impacting product quality or regulatory compliance
- Escalate significant concerns to EQ Site Leads and EQ Management as needed
- Review and approve J&J and CMO change controls, ensuring proposed changes are assessed for impact on product quality, regulatory compliance, and operational consistency
- Ensure all changes are properly documented, risk-assessed, and aligned with J&J quality standards and global procedures
Requirements
- Strong understanding of the production and release requirements for biologic products in the EU and associated regions
- At least 5 years of experience in an FDA or similarly regulated environment with a focus on Quality Assurance
- A minimum of 3 years of experience with pharmaceutical Good Manufacturing Practices (GMPs), preferably in biopharmaceutical QA
- Excellent interpersonal and communication skills to work effectively with diverse teams
- Proficiency in using process excellence tools and methodologies to enhance efficiency
- Fluency in English is required
Benefits
- Flexible work arrangements
- Hybrid work model
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
batch record reviewrecords managementdeviation managementCAPA managementChange Control oversightcompliance assessmentrisk assessmentquality standardsGood Manufacturing Practicesbiologic product release
Soft skills
interpersonal skillscommunication skillsrelationship buildingproblem-solvingteam collaborationproactive identification of riskstimely resolutioneffective escalationorganizational skillsattention to detail