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Manager, Quality Systems
Requisition ID: 9951180116
Johnson & Johnson Consumer Inc, a member of Johnson
& Johnson's Family of Companies, is recruiting a Manager, Quality
Systems to be located in Fort Washington, PA.
Johnson & Johnson Family of Companies touches more than
a billion people’s lives each day through our health care products and
services, our corporate giving, and the volunteer efforts of our employees. The
Johnson & Johnson Group of Consumer Companies develop and market beloved
brands that address the needs of consumers and health care professionals
worldwide. Our portfolio ranges across several distinct business units: Baby
Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and
Over-The-Counter (OTC) products.
The Manager, Quality Systems is responsible for providing
oversight of the USOTC Fort Washington Quality Systems. This includes responsibility for the Change
Control, APR (Annual Product Review), Document Control, and Training Quality Systems.
The Manager, Quality Systems is responsible for directing
compliance results across the site and for providing support during the
preparation and management of internal and external audits and driving
continuous improvement within the Quality Systems.
Responsibilities include but are not limited to:
- Provide strategic oversight to the Fort Washington Plant Quality Systems including partnering with Home Office to develop and implement continuous improvements. Serve as Site Process Owner for Change Control, APR, Document Control and Training Quality Systems.
- Provide leadership and oversight to the Fort Washington Change Control process ensuring that change controls are properly assess and approved prior to implementation and that all deliverables are met prior to closure while ensuring timeliness.
- Drive the Annual Product Review process to assure reviews are performed in accordance with the quality system procedures and Health Authority regulations/guidelines and corrective actions are implemented as necessary.
- Provide oversight of the site GMP and technical training programs assuring training requirements are met.
- Provide oversight and leadership to the Document Control Quality System ensuring adherence to GMP and GDP regulations, including records retention and management for the site.
- Develop and report metrics related to the Change Control, APR, Training, and Document Control Quality Systems.
- Interact with Regulatory Health Authority representatives during inspections.
- Develop responses to Regulatory Health Authority observations directly impacting the US OTC Quality Systems.
- Deliver on the implementing improvement projects in the Quality organization to sustain site compliance.
- A minimum of a Bachelor’s Degree is required with preference in Science and Engineering. MBA degree is also preferred.
- A minimum 8 years of experience in the Quality, Technical Services, Compliance and/or Manufacturing Operations in a GMP highly regulated environment is required.
- Demonstrated experience with leading teams or projects is required.
- Knowledge of production and manufacturing operations is required.
- Direct people management experience is required.
- Thorough knowledge of cGMPs and regulatory requirements/guidance is required.
- Experience interacting with Regulatory Health Authorities is preferred.
- Experience working with quality systems is required.
- Experience developing and maintaining metrics is required.
- Experience with instructional design and/or curriculum design is a highly preferred.
- Strong technical writing experience is preferred.
- Knowledge of IT systems (e.g., LMS, EDM, ERMS, EtQ) is preferred.
- Change management experience or roll-out of major initiatives is preferred.
- Front room experience working with regulatory agencies is preferred.
- Quality Auditor, Process Excellence, Project Management (FPx, PMP) certifications are preferred.
- This position may include up to 10% local travel as needed.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)