Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description: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 SummaryThe 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.
Key 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.
Experience and Skills:Required:
- 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
Preferred:
- Strong Analytical capabilities
- Experience is writing regulatory communications
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
