Senior Manager, ATSC External Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

All Job Posting Locations:

Gaithersburg, Maryland, United States

Job Description:

Johnson and Johnson is recruiting a Senior Manager, ATSC External Quality located in Gaitherburg, Maryland.

 Key Responsibilities:

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

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

• Provide oversight for tech transfer and new product introduction activities in the CART 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

• 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

 

Experience and Skills:

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

• Experience in CART manufacturing, testing and release

• 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 CART or Biologics products

• People management experience

 

Other:

• This position may require up to 30% travel and routine on-site presence

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 an