HireDiversity

Fort Washington, PA, US

GMP Compliance Audit Manager-4948121211

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a GMP Compliance Audit 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, and SUDAFED® nasal decongestants.

The GMP Compliance Audit Manager, Regulatory Compliance External Auditing (RCEA), plans, organizes, and conducts external cGMP compliance and quality audits of contract service providers and suppliers to ensure compliance with US FDA and international regulations, McNeil Consumer/ Johnson & Johnson Quality Standards, and applicable specifications. This individual is responsible for ensuring audit schedules are followed and revised upon management approval, audit documentation including agendas and reports are issued in a timely manner, and audit related corrective actions are completed from previous audits. The Audit Manager will organize audit teams, plan, schedule, and conduct external GMP compliance audits and ensure that critical issues are communicated to Senior Management.

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 is required. A focused degree in a scientific or closely related discipline is preferred. An advanced degree is desired. At least 5 years of work experience in a heavily regulated GxP environment OR contract service provider environment (Quality Assurance, Quality Control, Manufacturing departments) is required. A minimum of 3 years of quality auditing experience in GMP arenas is required. A Certified Quality Auditor (CQA), or similar certification is highly desirable. Experience in vendor management and oversight of contracted audits is highly preferred. Detailed understanding of industry auditing practices to FDA GMP (21 CFR part 11, 58, 210, 211, 820) is required.

Good interpersonal, verbal communication and writing skills are required. The ability to observe processes and interpret compliance risks is essential. The ability to influence and negotiate without direct line authority is required. This candidate will also be able to uphold the strong compliance values with external providers.

This position will be based in Fort Washington, PA and will require up to 50% (of mainly domestic) travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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