SITE QUALITY CD LEAD Job in Fort Washington, Pennsylvania US
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Site Quality Consent Decree Lead for its location in Fort Washington, PA.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL acetaminophen products, ZYRTEC and BENADRYL allergy medicines, IMODIUM A-D anti-diarrheal, MOTRIN IB, Mylanta and ROLAIDS antacid products, and SUDAFED nasal decongestants.
McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the JJ family of companies or beyond, or whether this is your entry to the JJ family of companies, we invite you to join us....
Creating the future of McNeil
The Site Quality Consent Decree Lead is responsible for the oversight, integration and implementation of the McNeil 19 Quality System Elements for effective and sustainable compliance.
The Site Quality Consent Decree Lead will report to the Site Quality Lead to augment the responsibilities of site Quality leadership/management in order to ensure the timely and successful execution of the Consent Decree workplan, including review and approval of site GMP documentation required to implement and demonstrate evidence of CD workplan step completion. This individual will ensure that individual CD workplan workstreams are properly coordinated at the site level for efficient and compliant implementation and integration into the site Quality Systems and associated business systems. The individual will partner with Quality, Operations and other GMP and non-GMP functional area leadership and team members at the site to clarify requirements, boundaries and expectations. This individual will ensure consistent practices are in place and aligned throughout the site. As needed, individual will backfill site Quality leads/managers to free them up for participation in CD-related activities.
Qualifications
A minimum of a Bachelors degree is required, technical or scientific discipline is preferred. An advanced degree is preferred. A minimum of 8 years of experience in an FDA-regulated, GMP quality and/or compliance environment is required. Experience in the Pharmaceutical, Medical Device and Diagnostic and/or OTC industry is required. Quality System design and implementation, particularly in regards to non-conformance, CAPA and/or validation is highly desirable. GMP Quality Audit experience is highly desirable. CQM, CQE or CQA is desirable. Experience with Six Sigma Process Excellence tools, training and/or certification is desirable. Experience with documentation and technical writing skills, in a regulated compliance environment, is required. Experience leading and/or managing people is required.
Strong influencing, negotiating and leading without direct line authority experience is required. The ability to manage complexity and cooperate with a diverse team is critical. Excellent written and oral communication and interpersonal relationship skills are required.
Assignment duration of the Site Quality Consent Decree Lead to last approximately three years.
All McNeil employees are required to cultivate an environment of quality compliance in their actions. This includes attending all required training, adhering to the processes procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create maintain an environment that promotes employee involvement and doing things right the first time.
This position may require up to 10% travel domestically and internationally and is located in Ft. Washington, Pa.