Sr Mngr External Quality - Adv Therapies

evant safety, regulatory compliance, and product quality standards.

You will provide QA support for technology transfer, EM qualification, manufacturing quality oversight and release and improvement of manufacturing and supply processes. You will monitor quality performance of the EM's, proactively identify risks and lead improvement programs to mitigate. This position may lead a work team as needed, located on-site as well as remote, that is responsible for delivering the site quality goals.

Key Responsibilities

• Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites working in the radiopharmaceutical space

• Lead quality oversight in the selection, qualification, and ongoing monitoring of external partners

• Provide oversight for tech transfer and new product introduction activities in the radiopharmaceutical space; lead PAI readiness activities, and support associated health authority filings and approvals

• Daily management and coordination of the EQ 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

• Monitor 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 the 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

Education:

• Bachelor's Degree in pharmaceutical, engineering, science or equivalent technical field

Required:

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

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

• Detailed knowledge of current Good Manufacturing Practices related to (radio-)pharmaceuticals

• Experience in quality oversight for commercial manufacturing operations

• Experience working with external partners

• Experience in aseptic pharmaceutical manufacturing

• Experience in radiopharmaceutical manufacturing, testing and release

• Strong interpersonal and written/oral communication skills

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

Preferred:

• Experience in setting up and launch of a new supply chain

• Experience in Biologics products

• People management experience

Other:

• This position may require up to 25% of domestic and international travel

• The salary for this position is anticipated to be between $120,000 to 207000

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company's long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com.