Quality Account Manager (1 of 2) Job in Fort Washington, Pennsylvania Us
McNeil Consumer Healthcare, a Division of McNeil-PPC, Inc, a member of the Johnson Johnson family of companies, is recruiting for a Quality Account Manager for its location in Ft. 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 Account Manager, External Manufacturing Quality will support the production of new and transferred OTC Drugs and Medical Devices. The Quality Account Manager will represent External Manufacturing Quality Assurance on existing commercial products, new projects, product transfers and improvement teams by guiding technology transfer decisions, setting project quality/compliance requirements, developing SOPs specifications as needed, and providing technical transfer/validation support for commercial products. The Quality Account Manager will be key to the selection, qualification and on-going management of new contract manufacturing locations through cGMP audits, driving compliance quality improvement initiatives, assisting in the resolution of process/product nonconformance events, monitoring/resolving product complaints, and review of Product Quality, reporting Contract Manufacturer performance metrics, and conducting management reviews.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations Companies' policies, procedures and guidelines, this position: Supports GMP and JJ policy assessments during due diligence phase in support of new ventures. Implements the McNeil Quality and Compliance program and drives improvement policy at outsourced operations. Helps resolve supplier and external manufacturer Quality and Compliance issues for new transfers. Approves all non-conformance investigation reports, change controls, and validations/qualifications documentation requirement for new product transfers. Attends key EM business unit reviews and develops/drives strategic improvement initiatives for new product sites. Collects and analyzes External Manufacturing Quality and Compliance metrics. Takes action as appropriate. Directly and independently engages in tactical assessment, monitoring, and control of a group of new external manufacturers. Visible leader of challenging regional or CQA initiatives that elevate compliance, improve department efficiency, and/or establish new policies/procedures. Develops and implements strategies to leverage other resources to streamline External Manufacturing processes, standardize practices and eliminate non-value added work. Participates in change control meetings and responsible for approval of deliverables in an appropriate timeframe. Oversee Quality performance (on-going) at external services providers. Review performance against stated goals in the contract, quality agreement, or internal/ industry standards. Integrate quality aspects of the EM relationship with other business needs. Responsibilities include, but are not limited to oversight of: Nonconformance investigations, Verifying Implementation of Change Controls, Manufacturing/ Packaging Directions, Stability Management, Product Reviews, Performance and Business Matrix.
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, as well as create and maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A Bachelor's Degree in Engineering, Life Science, Physical Science or related discipline is required; An advanced degree is preferred. A minimum of ten years experience in the pharmaceutical arena or in an FDA-regulated industry required. Candidate must exhibit broad knowldege 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 and expert knowledge of product technical transfers and process validation is required. Cleaning validation experience, and microbiological equipment train design standards is preferred. Experience working on cross-functional Project teams required. Understanding of product development, product stability and microbiological principles prefered. Demonstrated ability to manage Quality issues and drive resolution is required. A strong ability to interact effectively with a diverse group of individuals and the ability to work independently on complex issues; serving as a subject matter / technical expert within the functional area is required. Excellent analytical, prioritization, communication, and strong leadership skills are necessary as is the ability to communicate with and influence all levels of the organization. Candidates must be team oriented, comfortable with a hands on approach and able to function with personnel at various levels within the organization. Strong leadership and project management skills and abilities are required and candidates must be detailed oriented and committed to achieving organizational goals objectives. A Process Excellence or Six Sigma Certification is preferred as is an ASQ Certified Quality Engineer or Auditor Certification. This position will be based in Fort Washington, Pa. and will require up to 25% domestic and international travel.