Manager Quality Assurance

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•$102,000 - $177,100•Hybrid

About The Position

Johnson & Johnson is currently recruiting for a Manager Quality Assurance. This position can be located in New Jersey or Pennsylvania with a preference for Raritan, NJ. Position Summary The Manager, Quality Assurance provides leadership and oversight for specified external manufacturers of Advanced Therapy products, ensuring consistent delivery of pharmaceutical products from the external manufacturer that meet all required safety, regulatory compliance, and product quality standards. The Manager leads people, influences stakeholders, and ensures sustained inspection readiness and regulatory compliance. 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. Position may require up to 30% travel.

Requirements

8+ years working in an FDA/EMA regulated environment.
Bachelor’s degree in a scientific, technical, or related discipline required.
Extensive knowledge of Quality Assurance, Quality Control and Compliance.
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
Experience managing quality oversight of external partners for commercial manufacturing operations
Experience in Good Tissue Practices and Biologics products
Experience in aseptic pharmaceutical manufacturing
Strong interpersonal and written/oral communical skills
Ability to take ownership for and own the resolution of complex Quality and Compliance issues with respect to External Manufacturing

Nice To Haves

Strong Analytical capabilities
Experience is writing regulatory communications

Responsibilities

Lead and oversee quality systems, processes, and controls to ensure effective and compliant execution of quality systems at external manufacturing sites.
Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners.
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.
Analyze quality metrics and trends to proactively identify risks and opportunities for improvement.
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 inclusive of follow-up on associated responses and commitments.
Serve as the Quality Assurance representative on cross‑functional project teams, providing compliance guidance and risk‑based decision‑making.
Drive continuous improvement initiatives aligned with business objectives and quality strategy.
Provide oversight for tech transfer and new product introduction activities
Influence stakeholders at multiple organizational levels and lead with or without direct authority.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year