HireDiversity

Fort Washington, PA, US

Quality Manager, External Laboratories (1 of 2)-1625121203

Description

McNeil Consumer Healthcare, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Manager, External Laboratories 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, and SUDAFED® nasal decongestants.

The Quality Manager, External Laboratories will support the contracted testing and/or storage of OTC Drugs and Medical Devices, including but not limited to release testing of raw materials, components, active pharmaceutical ingredients, finished products, stability testing, complaint and/or forensic sample assessment. The Quality Manager, External Laboratories will represent QACO in the selection, management & control of Contract Laboratories and will be key to the identification, qualification & ongoing management of CLs used by McNeil sites through collaboration with procurement & sending sites. The Quality Manager, External Laboratories will participate in and/or evaluate cGMP audits and develop and negotiate Quality Agreements. The Quality Manager, External Laboratories will provide MCH site support by identifying suitable laboratory(ies) for required testing, participating in change control activities to qualify the laboratory(ies), including but not limited to review and approval of method transfer protocols & reports, verification protocols & reports for compendia materials and method/specification comparison memos. The Quality Manager, External Laboratories will assist in the resolution of nonconformance events as needed, data review, and the review of regulatory submissions associated with testing activities or changes, as applicable. The Quality Manager, External Laboratories will further maintain the qualified material/product lists for each laboratory, maintaining up to date approved testing tables for each contract lab location. The Quality Manager, External Laboratories will drive compliance & quality improvement initiatives through reporting and assessment of cumulative performance metrics and conduct of management reviews.

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 a Bachelors degree with at least 8 years of experience in a GMP Pharmaceutical environment is required. An Advanced Degree is preferred. A focused degree in Chemistry, Life Science or a related discipline is required. Diverse chemistry expertise with demonstrated ability to solve complex problems in HPLC method development, organic chemistry, UV-VIS, dissolution and wet chemistry techniques is preferred. Candidate must exhibit broad knowledge of Quality Assurance principles and practices in the pharmaceutical, biological, and/or OTC Drug product industry. Expert Knowledge of cGMP requirements and current FDA enforcement issues, expert knowledge of analytical or microbiological testing requirements & laboratory instrumentation, method transfer requirements, method validation, and compendia requirements is required. Experience working on cross-functional Project teams required. Understanding of product development, product stability and microbiological principles is prefered. A Process Excellence/Six Sigma Certification or ASQ Certified Quality Engineer or Auditor is highly preferred. Candidates must possess a demonstrated ability to manage Quality issues and drive resolution as well as work with a diverse group of individuals. Excellent written and oral communication skills are required. The ability to influence others without direct line authority is highly preferred. The ability to work independently on complex issues serving as a subject matter/technical expert within the laboratory functional area is required. This position will be based in Fort Washington, PA and may require up to 25% travel.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Relocation: Eligible
Yes - Within Country