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Fort Washington, PA, US

Sr. Manager, Quality Control - Analytical Laboratory-1925121206

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Sr. Manager, Quality Control (QC) Analytical Laboratory 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 Sr. Manager, QC Analytical Laboratory will be responsible for ensuring that the operations of the QC Analytical Laboratory comply with company and regulatory agencies' regulations pertaining to the manufacture of our products. This individual will coordinate the most effective use of the laboratory, the QC testing of components, in-process materials and finished products, finished products, and the marketed product stability program for finished products for the Fort Washington Plant. The Sr. Manager, QC Analytical Laboratory will assure compliance with current Good Manufacturing and Laboratory Practices in all the activities of the operation; provide direction and leadership for the QC Analytical Laboratory developing staff to improve individual and departmental performance; develop and implement departmental procedures in accordance with cGMPs and Company policies, standards and guidelines. This individual participates in the development and implantation of Company laboratory standards and procedures and provides training to members of the department and other departments as necessary.

The Sr. Manager, QC Analytical Laboratory will oversee the qualification of new equipment and the on-going re-qualification of existing equipment. This individual manages the laboratory equipment qualification, calibration and Preventive Maintenance programs assuring the QC Analytical Laboratory is qualified for their intended use. This individual audits the laboratory for compliance to cGMPs and safety requirements; manages all laboratory projects from internal and external departments, suppliers and sub-contractors; develops and implements systems and training to ensure successful completion of these projects; manages the planning and scheduling of the laboratory for maximum effective utilization of employees, equipment and material.

The Sr. Manager, QC Analytical Laboratory will forecast the need for new equipment and staffing to serve expanding operational and regulatory requirements sufficiently in advance of the need; review method transfer and qualification protocols and reports as necessary; oversee laboratory investigations to assure timely notification to management of results and resolution of issues; provide input for risk assessments; provide data trending in support of annual product and quality system reviews; develop departmental and site metrics to detect potential signals and drive improvements; participate on teams for new product introductions and post-approval/launch changes. This individual will interact with Regulatory Health Authorities during inspections and provide input to responses to Health Authorities. This person will also develop, administer and control department budgets.

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 in Chemistry or a Natural Science is required. An advanced degree is preferred. At least 10 years of experience in the pharmaceutical industry or other highly regulated industry is required. A minimum of three years of supervisory experience is required. Experience with cGMPs and cGLPs are required. Thorough understanding of wet chemistry and instrumental analysis is necessary. Experience leading a QC Analytical Laboratory is required. Experience overseeing a Laboratory equipment qualification, calibration and preventative maintenance program is highly preferred. Experience interacting and negotiating with Regulatory Health Authorities is preferred. Validation of analytical (Type C instrument) computerized systems is preferred. Knowledge of statistical concepts and data trending is preferred.

The selected individual must have good interpersonal skills needed to lead a group at all levels, demonstrate good management skills and leadership ability. They must be highly skilled in prioritizing work, influencing, and resource planning. Excellent oral and written communication skills are a must for this position.

This position is located in Fort Washington, PA.

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