DescriptionMcNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Manager, Quality Management Systems located 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, ROLAIDS?? antacid products, and SUDAFED??
nasal decongestants. The Quality Management Systems Manager will support the Quality Systems groups in McNeil Consumer Healthcare. This individual is responsible for ensuring ongoing QA compliance functions are met relative to Annual Product Reviews (APR) across all McNeil sites. Specifically, the Quality Management Systems Manager supervises the activities of the APR Program.
This individual assures that the annual schedule is maintained and that APRs are completed as scheduled; facilitates completion of the management review requirement to meet expected APR completion dates; delivers APR presentations/metrics as needed to both site staff and Quality Management. As necessary, this individual updates Standard Operating Procedures (SOPs) and APR database. The Quality Management Systems Manager may also be required to participate in cross functional teams providing compliance support as needed. This individual will strive to continuously improve the process by optimizing reporting and presentation of information.
This individual will evolve the program to continuously meet current enforcement guidelines (cGMP), provide support to the McNeil Quality Systems group (APR) and performs other related duties as required. 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.
QualificationsA minimum of a Bachelors degree required. A focused degree in a technical discipline such as Chemistry, Biology, Microbiology, Virology, Engineering or Pharmacy is preferred. A minimum of 5 years of related work experience in a pharmaceutical and/or biological manufacturing operation focused on Quality Assurance and Quality Systems is required. Strong knowledge of cGMP requirements and current FDA enforcement issues are required.
The ability to analyze data using statistical tools is necessary. Experience writing and putting together Annual Product Review summaries is also required. Prior supervisory experience is preferred. Proficiency with Microsoft Office is required.
This role requires keen attention to detail, a demonstrated ability to maintain positive working relationships with others and expertise in handling multiple priorities. The ability to negotiate and influence is necessary. This position is located in Fort Washington, PA and requires up to 10% travel. BE VITAL in your career, Be seen for the talent you bring to your work.
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- 2 years ago - save job