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Quality System Manager, NC/CAPA
Requisition ID: 6974180329
Johnson & Johnson is recruiting for a Quality System Manager, NC/CAPA to be located in Raritan, New Jersey.
With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
This position provides Quality & Compliance (Q&C) oversight for all J&J Technology Services Nonconformance and CAPA investigations. She/ He will provide compliance support and quality leadership to JJTS and JJTQ in the investigation, resolution and documentation of individual quality problems and trends. This position will also be responsible for monitoring for quality issues within the Service Reliability meeting to identify events or trends that require Nonconformance and CAPA investigations.
You, the Quality System Manager, NC/CAPA will:
- Have frequent interaction with JJTS & JJTQ Management.
- Identify compliance risks in JJTS processes and procedures
- Ensure that Nonconformance (NC) Investigations and Corrective Action/Preventive Action (CAPA) plans are implemented to resolve these risks.
- Ensure that NC Investigations and CAPA plans are appropriate and addressed in a timely manner.
- Review and approve NC Investigations and CAPA reports.
- Participate in and provide quality leadership for routine Operations Meetings including Service Reliability.
- Supervise and mentor NC/CAPA department staff.
- Provide support to Regulatory Compliance during internal and external audits.
- A bachelor’s degree and a minimum of 8 years of experience in a regulated environment is required.
- A minimum of 3 years managing root cause investigations processes in a regulated environment is required.
- People management experience is preferred.
- Extensive knowledge of cGMP's is required.
- Excellent communication (verbal and written), leadership, influencing & negotiating, and collaboration skills are essential.
- A proven track record of selling ideas to management, resolving complex compliance issues, and delivering on business results is preferred.
- Working knowledge of Nonconformance and CAPA processes in a regulated environment required.
- Strong decision making and analytical skills and the ability to manage multiple projects at the same time is required.
- This position will be located in Raritan, New Jersey and may require up to 10% domestic and or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Johnson & Johnson Services Inc. (6090)