Sr. Manager Quality Validation-5429140925
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Sr Manager Quality Validation, located in Fort Washington, Pennsylvania.
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 and SUDAFED® nasal decongestants.
The Sr Manager Quality Validation will provide quality oversight to the site qualification of equipment, process and cleaning validation, supplier quality related non-conformances and product complaints .. This position will ensure adherence to McNeil, J&J and Regulatory Health Authority Requirements in addition to the Site Master Plan and Validation Master Plan.
The Sr Manager Quality Validation will manage site qualification and validation programs for facility, equipment and manufacturing and packaging processes utilizing Quality Risk Management tools. Support the development and maintenance of the Site Master Plan. Support the development and deployment of facility and equipment qualification and manufacturing and packaging standards, policies and procedures for McNeil Fort Washington Site. Provide quality support and oversight to the criticality assessment process. Support the introduction of new products to assure compliance to all standards and robust product supply. Communicate to management in accordance with the management event and notification quality system procedure. They will interact with Regulatory Health Authority representatives during inspections. Support responses to Regulatory Health Authorities. Responsible for Participation on the Validation Review Committee as required. Assist in the identification of qualified representatives from Quality Operations and the appropriate technical functions to be responsible for the determination of process validation requirements appropriate for each manufacturing process. This position will be responsible for the preparation, review and approval of validation protocols. They will responsible for ensuring that necessary samples are taken and collected as well as delivered in support of validation activities and these are accomplished according to the sampling plan and in a timely manner. Responsible for collecting and providing required APR/PQR quality attribute data and analysis of that data.
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.
Qualifications
A minimum of Bachelor of Science degree is required. An advanced degree is preferred. Minimum 10 years of experience in the Quality, Technical Services, Compliance and/or Manufacturing Operations in the OTC and/or pharmaceutical manufacturing industries is required. Minimum 3 years of direct experience in a management role is required. Knowledge of production and manufacturing operations is required. Knowledge in GMP and pharmaceutical industry applicable regulations (21CFR, Parts 11, 210 and 211) is required. Excellent time management skills are required. Ability to make risk based decisions is required. Ability to negotiate and interact effectively with regulatory agency representatives is required. Knowledge in Process Excellence, Lean Six Sigma techniques is preferred. Basic knowledge in Microsoft Office (Word, Excel, PowerPoint and Outlook) is required.
This position is located in Fort Washington, Pa and will be required to travel 10%.
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Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job Function: Validation
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