HireDiversity

Fort Washington, PA, US

INSPECTION READINESS LEAD-0205130125

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Inspection Readiness Lead, 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.

The Inspection Readiness Lead will drive all aspects of regulatory inspection readiness for the Fort Washington site. This includes ensuring documentation is accurate, thorough and presentable for inspection. While preparing for inspections, the Inspection Readiness Lead will perform internal compliance verification of documentation, ensure documentation meets stated requirements, and identify evidence gaps for consideration. TheInspection Readiness Lead will be required to interface with all staff to troubleshoot compliance issues, gain an appropriate understanding of documentation as well as request additional documentation or modifications to existing documentation. Additionally, this role will ensure logistical aspects of inspection readiness are constantly maintained and available to facilitate any inspections. This includes use of the ATMS system, training of staff for staging room activities, maintenance of inspection tools, etc. During an inspection, the Inspection Readiness Lead will be responsible for managing the document staging area and the overall inspection process to facilitate a successful outcome. The Inspection Readiness Lead will also ensure responses to regulatory agencies are completed and issued within the assigned time frame, compile necessary regulatory commitment defense packages in an organized manner and maintain this structure over time. Upon response to a regulatory agency, this role is responsible for tracking, coordinating and driving completion of committed actions. The Inspection Readiness Lead may also participate in regulatory agency notifications such as field alerts, recalls, desktop audits, etc.

Develop and manage the site personnel to effectively interact with inspectors during a regulatory inspection. Initiate and maintain extensive contacts with key representatives of McNeil Consumer Healthcare and other organizations and companies both inside and outside the J&J family of companies. Work alongside Site Quality, Site Operations and the third party GMP expert group. Communicate and train local personnel on corporate policies and guideline, work plan expectations, regulatory and compliance trends, and new changes within the review process.

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.

J2W:LI

Qualifications


A Bachelors degree is required. A degree in Biology, Chemistry, Microbiology, Engineering or related technical degree is highly preferred. Minimum 6 years of pharmaceutical quality experience with proven success in quality systems/compliance environment is required. A broad background in all aspects of quality systems and pharmaceuticals is required. Internal/external auditing experience is preferred. Experience working with Board of Health inspections is required. Active cGMP interpretation and application experience is required. Strong organizational skills/facilitation skills are required as is strong verbal, written and presentation skills. This position will be located in Fort Washington, Pa. and will require up to 10% travel.

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