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Quality & Compliance Site Director – Production (MAKE)
Requisition ID: 3977180221
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality & Compliance Site Director – Production (MAKE) to be located in Lititz, 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 Quality & Compliance Site Director – Production (MAKE) will direct all aspects of the Quality Unit operations at the Lititz Plant.
In this role, you will have full ownership of the manufacturing site’s quality systems. You will provide leadership and counsel to the achievement of sustained compliance with regulatory bodies, other applicable government GMP regulations and Enterprise Standards in all plant activities. You will also support development of leading edge quality systems, provide counsel to and interpretation of current/emerging compliance trends and ensures Quality MAKE talent development to meet current and future needs of the organization.
Responsibilities include but are not limited to:
- Leads the Site Quality Unit in accordance with cGMP. Involved with directing the Plant Quality team, The Quality systems team, the site QEx team and the Q&C units.
- Develop strategies designed to assure compliance with Quality Systems
- Provide leadership /support for development of Quality standards impacting the site
- Supports and ensures the deliver\y of the site KPIs and the Quality unit targets, goals and objectives (Safety, quality, compliance, customer service and efficiencies)
- Oversees the analytical and microbiological laboratory testing to assure the identity, quality, purity, strength and suitability of all raw materials, containers and closures, in -process and finished products.
- Oversees the day to day operations of the Plant Quality team managing the production floor.
- Represents the Company in all contact with the FDA, and other government regulatory agencies where appropriate.
- Forecasts needs for capacity, new instruments, equipment and personnel to support market growth, expanding operational regulatory requirements, sufficiently in advance to be in place when needed while developing and administering the overall Quality department budget.
- Aids in developing the site’s next set of leaders and emerging talent by providing coaching, mentorship and adequate career challenges as needed.
- A minimum of a Bachelor’s degree in Sciences is required. A focused degree in Chemistry, Pharmacy or Analytical Chemistry highly preferred. A Masters or Ph.D is preferred.
- A minimum of 10 yrs working within GMP highly regulated environment is required.
- Senior leadership experience is required, including line management of multiple levels of direct reports.
- Previous Pharmaceutical and/or Consumer OTC industry experience is required.
- Previous experience with all contact with the FDA, and other government regulatory agencies is required.
- Extensive knowledge of cGMPs and manufacturing operations is required.
- The ability to manage multiple projects as well as a high degree of complexity while dealing with different matrix organizations is required.
- This position may require up to 15% domestic and international travel including some nights and weekends.
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.
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,
J & J Consumer Inc. (6101)