QA Validation Manager CD Job in Fort Washington, Pennsylvania US
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. is currently recruiting for a QA Validation Manager, 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, 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 QA Validation Manager will provide quality oversight to site facilities, utilities and equipment qualification and process, packaging, computer system, and cleaning validation. Manager will also interface and support Engineering and Validation with respect to reports of deviations which may impact product quality. Will ensure adherence to McNeil, JJ and Regulatory Health Authority Requirements in addition to the Site Validation Master Plan.
Review and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes and strategies. Assists in development of company validation and/or qualification standards. Approves validation, quality and engineering procedures, strategies and master plans. Complies with policies, procedures, and company and regulatory norms. Proceeds according to quality standards and policies in all business activities with providers and customers within and outside the company. Acts as a lead in identification of validation constraints for equipment and/or performance processes and/or conducts equipment qualification activities. Participates in project teams as desired by management. Serves as the training liaison for departmental validation training requirements and develops technical training content. Collects data, prepare reports and provide information required. Assist other departments throughout the facility in achieving their objectives by providing technical evaluations, opinions and recommendations. Serves as department head in absence of the QA Validation Manager 2. Provides a high level of technical and relational contribution. Has an understanding of all Quality functions and business areas. Works independently on routine and complex issues. Recommends and supports technical and process improvements. Serves as a subject matter expert within functional area and during inspections by regulatory health authorities. Supports the Manager 2 in establishing validation and qualification strategy for the site. Oversees the maintenance of the validated state including requalification/revalidation of equipment and processes. Approves commitment closure documentation for accuracy and completeness and applicability to the commitment deliverable. Participation in team meetings/discussions for development of CARs, POs, and RFPs. Technical lead in the development of the Master Validation Plans, Project Plans, and Test Plans. May approve these plans in absence of the Manager 2. Leads and/or conducts VDQA, Risk Assessment, and Deviation/TIR process. Authors, reviews, approves and edits SOPs, Standards, and Guidelines as necessary. Monitors and follows up for ensuring timely completion of all commitments. Responsible for assuring action plans fully address observations and verifies quality of actions taken prior to recommending closure of commitments in tracking system.
This position will also work within Regulatory: Directly interacts with regulatory agents/inspections. Supports development of strategy and executes PAI readiness plan inspections. Organizes and analyzes data so that the appropriate action can be taken. Be able to evaluate document requests, stage documents as requested, and provide review of documents as requested. Support development of responses to observations. Conducts and/or leads audits. Approves investigations assuring proper utilization of appropriate investigation tools (e.g. 5 Why's, fishbone, 6Ms), identification of true root cause and implementation of appropriate corrective and preventive actions. Assure adherence to Notification to Management procedure.
In a timely and prompt manner, the Manager QA Validation will identify, report and seek correction for deviations noted in the workplace. Works with validation team and site leadership to ensure all aspects of business remain compliant. May supervise contractors. Trains new employees. Provides feedback to department management. Reviews, and approves change controls/engineering change notices, investigations, discrepancies/deviations, and audit responses. Lead/mentor documentation periodic review activities. May have formal responsibility for performance development. Suggests and implements tactical direction for functional area.
Qualifications
A Minimum of Bachelors degree in Science or Engineering is required. An advanced degree is preferred. A minimum of 9 years of experience in quality and validation roles within a GMP environment is required. Expertise in writing, reviewing, and approving technical documents is required. A strong knowledge of multiple validation disciplines, and good knowledge of all validation disciplines is a requirement. An overall strong Quality background is required. An expert knowledge/understanding of drug manufacturing and packaging processes, the product development life cycle from sampling and inspection through warehouse distribution is required. Excellent knowledge of various computer systems is required such as, SAP, Compliance Wire, TrackWise, POET, EDM, MS Office (including Outlook, Word, Project, Excel, PowerPoint). An intermediate understanding of PLC programs is required. The ability to interpret and apply GMP requirements and the conceptual understanding of all Quality functions and business areas is required. The ability to benchmark industry trends and apply results is required. Previous supervisory experience and line management experience is required. Previous experience coaching and guiding a technical staff is required, as is the ability to use effective mediation and conflict management, negotiation, and internal/external influencing skills. Experience with liquid and solid dose manufacturing is required. Lean/Six Sigma training or certification is preferred. This position will be based in Fort Washington, Pa. and may require up to 25% travel.
Assignment duration of the QA Validation Manager CD 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.