External Quality Manager LM EMEA– Manufacturing Support

We are searching for the best talent to join our team to support the quality oversight of External Manufacturers (CMOs - Contract Manufacturing Organizations).

Purpose:

As External Quality Manager LM EMEA– Manufacturing Support, you will play a key role in supporting the External Quality EMEA team in the oversight of the External Manufacturers portfolio for Large Molecules. Your focus will be on quality and compliance activities including batch record review, records management, deviation and CAPA management, and Change Control oversight.

This position offers flexibility in location and can be based at any Johnson & Johnson site within the EMEA region.

Key Responsibilities

Batch Record Review

• 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.

Deviation & CAPA Management

• 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.

Change Control Oversight

• 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.

Education:

Minimum of a bachelor’s degree in Science, Medical or equivalent technical field is required.

Experience and Skills:

Required:

• Strong understanding of the production and release requirements for biologic products in the EU and associated regions, including deviation management.
• 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.

Preferred:

• Shown experience overseeing external manufacturing operations or quality assurance for external manufacturers.
• Experience in Batch Record Review/Release.
• Experience in Quality Risk Assessments.
• Solid understanding of Eudralex Annex 1 has a strong preference.

• This position can be based a the J&J IM site in EMEA.
• This position might involve regular travel up to 10%.
• At Johnson & Johnson IM, we embrace a hybrid work model that balances in-office collaboration with remote work flexibility. Working on-site a minimum of 3 days per week at the Johnson & Johnson site, fosters collaboration while allowing for remote work flexibility on remaining days.