Sr. Manager, MQSA (Microbiological Quality and Sterility Assurance)

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

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

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  

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Sr. Manager, MQSA (Microbiological Quality and Sterility Assurance).

SUMMARY

Leading expert individual contributor who is viewed as a valuable resource by peers, who manages large projects or processes. Develops methods related to the quality requirements for areas such as microbiology, sterility, and vaccines. Assists in designing vision for the testing, research, and reporting required to uphold quality standards. Leads adherence to compliance regulations through routine audits and safety checks.

JOB DESCRIPTION

An individual contributor with Microbiological Quality and Sterility Assurance industry-specific knowledge and who plans innovates and drives manufacturing process and facility design improvements that assure product quality and regulatory compliance.

• Integrates Johnson & Johnson’s Credo behaviors into team goals and practices.
• Stakeholder Coordination: Collaborate across various collaborators (including external consultants involved in the program) to ensure flawless integration of design, engineering, building, qualification, and approval stages for the automated GMP manufacturing facility.
• Applied Scientific Expertise: Contributes to a broad audience Microbiological Quality and Sterility Assurance knowledge on topics including, cleaning, disinfection, gowning, aseptic processing, clean room operation, and environmental monitoring.
• Project Familiarity: Serve as a vital resource, intimately familiar with manufacturing processes, decisions, and rationale throughout the facility's design, build, and qualification phases.
• Regulatory Assessments: Owns EU GMP Annex 1, Part 4, and US FDA ATMP Guidance assessments to ensure the facility exceeds external regulatory and internal Johnson & Johnson expectations. Identify areas requiring remediation and swiftly inform stakeholders. Lead the mitigation strategy development and support the identification of suitable solutions fitting the automated process vision.
• Regulatory and Quality Alignment: Liaise with J&J Regulatory, Quality, and Environment Health & safety (EHS) teams to inform, align, and address potential compliance concerns, ensuring adherence to the highest quality standards.
• Inspection Readiness: Partners with site Quality Assurance to lead audits and inspections, ensuring thorough preparation and successful outcomes.
• Tech Transfer Support: Facilitate technology transfer activities to other sites, contributing to the seamless expansion and adaptation of automated processes.
• Continuous Improvement: Drive initiatives aimed at reducing cost and complexity within manufacturing processes, while minimizing regulatory and patient risk.

QUALIFICATIONS

• 8-10 years’ experience

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource

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