External Quality Manager-large Molecules

**Job Description**:
Johnson & Johnson Innovative Medicines (IM) is looking for a Manager, External Quality Large Molecules.

Work Environment:
At Johnson & Johnson IM, we embrace a hybrid work model that effectively balances the advantages of in-office collaboration with the flexibility of remote work. For this role, you are expected to work on-site a minimum of 3 days per week. This on-site presence is vital for fostering collaboration and engaging with cross-functional teams, ensuring that quality remains at the forefront of our operations. The remaining days of the week may be reserved for remote work, providing flexibility while allowing for team interaction.

This position can be based in J&J IM site locations Belgium, The Netherlands, Switzerland, or Cork.

Our Commitment:
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary:
In this role, you will play an essential part in maintaining the highest quality and compliance standards for our biologic products, specifically focusing on Drug Substance, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do

Key Responsibilities:

- Work hand-in-hand with Internal Quality Assurance Associates and External Manufacturers to conduct batch record reviews and complete release packages for global markets.
- Assess batch manufacturing records, deviations, and CAPA plans to identify issues that may impact product quality or compliance.
- Address quality-related issues proactively, bringing relevant concerns to J&J management for resolution.
- Collaborate and advise the External Quality Site Lead on how to resolve major quality challenges.
- Ensure adherence to established standards for J&J-specific manufacturing operations at external sites.
- Identify risks and potential issues that could impact product release timelines and drive resolution efforts.
- Support technical transfers at external manufacturing sites as our QA representative and provide quality oversight of Process Performance Qualification (PPQ) activities.
- Review and approve critical quality documents, including validation documentation, master batch records, and sampling plans.
- Stay flexible and open to taking on additional duties as needed.

**Qualifications**:
**Qualifications**:
**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 and/or Drug Substance production.
- 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 Quality Risk Assessments.
- Solid understanding of Eudralex Annex 1 has a strong preference.

Other:

- This position may require up to 10% travel

Why Join Us?

At Johnson & Johnson Innovative Medicines, we believe in the power of collaboration and innovation. As a Specialist EQ - Supplier Quality, you will contribute to improving the lives of patients worldwide through the development of advanced therapies. You’ll work in a dynamic and encouraging environment where your expertise and contributions will be recognized.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.