Sr Manager External Clinical Supply Quality

ring of external partners.

• Provide oversight for tech transfer and new product introduction activities in the radiopharmaceutical space.

• Daily management and coordination of the ECSQ work team supporting the EM as needed.

• Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.

• Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.

• Supervise quality performance through the development of key performance indicators; Analyze data to identify risks and drive implementation of mitigation plans.

• Build relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures passionate about reliability, execution, and quality culture.

• Collaborate with External Manufacturers to support health authority inspections; supervise and follow-up on associated response and commitments.

• Partner with External Manufacturing sites to define the quality strategy through benchmarking and knowledge sharing.

• Lead risk management initiatives vital to improve performance.

• Partner with key internal stakeholders in support of tech transfer and supply chain processes to meet patient supply requirements.

• Assess current quality systems and recommend improvements to improve compliance and optimize processes.

Qualifications

Required:

• A minimum of 8 years working in an FDA/EMA regulated environment.

• Extensive knowledge of Quality Assurance, Quality Control and Compliance.

• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.

• Experience managing quality oversight for commercial manufacturing operations.

• Experience working with external partners.

• Experience in aseptic pharmaceutical manufacturing.

• Strong interpersonal and written/oral communication skills.

• Ability to take ownership for and own the resolution of complex Quality and Compliance issues with respect to External Manufacturing.

Preferred:

• Experience in building a new supply chain.

• Experience in Biologics products.

• Experience in advanced therapies manufacturing, testing and release.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.