External Quality Manager LM EMEA– Manufacturing Support

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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About the Johnson & Johnson

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 personal. Through 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 humanity. Learn more at Medicines is a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus this group strives to provide access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

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 bachelors 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.

Other:

• 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.

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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource

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