HireDiversity

Fort Washington, PA, US

ASSOC DIR, GMP REGULATORY COMPLIANCE-4880121206

Description

McNeil Consumer Healthcare, a Division of McNeil-PPC, Inc, a member of the Johnson & Johnson family of companies, is recruiting for an Associate Diretor GMP Regulatory Compliance 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 Associate Director of Site Regulatory Compliance provides leadership for, and oversight of, compliance posture and integration of regulatory and quality requirements within a McNeil site. Report to, and work closely with, the Director of Network Regulatory Compliance. Provide expert cGMP compliance support for key McNeil production activities regulated by FDA, EMEA, and other key applicable regulatory bodies. Work closely with, and provide oversight to, site quality, operations, and technical operations leaders to foster issue resolution and risk mitigation. Will also liaise with key quality and compliance partners, including Consumer Sector and J&J ERC functions, particularly in areas of interest regarding regulatory requirements and risks.

Provide compliance oversight and proactively identify and prioritize compliance risks at assigned site. Assure compliance programs are implemented and maintained at the site. Identify compliance signals that warrant attention. Support deployment and implementation of the Quality Risk Management concepts to control risks and maintain vigilance. Work with business partners to mitigate compliance risk at manufacturing site. Provide Compliance support to strategic projects/initiatives. Provide active compliance support in the product lifecycle management process (e.g. new product launch, significant changes, etc.). Support site in preparing for Health Authority (HA) inspections (including Pre-Approval Inspections), assist sites during resolution progress and identify emerging shortfalls and risks for management notification. Provide compliance advice to Sites for critical issues and problem resolution. Support the Site with crisis management. Consult with, and support, site leaders for the escalation and resolution of Quality and Compliance issues. Actively participate in site escalations. Review investigations with high regulatory potential, including those associated with FARs & recalls. Make decisions regarding the applicability of cGMP and other Health Authority regulations to site. Support strategic alignment to J&J, Consumer Sector, and McNeil policies and standards. Provide proactive regulatory insight into new and upcoming regulations. Participate in the Site product/management review forums (e.g., Quality Councils) to uphold effective risk identification and management, quality system evaluation, and appropriate response to issues. Partner with Compliance peers within the group, at McNeil sites, and with Consumer Sector and Enterprise regulatory functions, as appropriate, for strategic consistency and leveraging opportunities. Maintain personal professional development on new/upcoming requirements and technologies.

All McNeil employees are required to cultivate an environment of quality and 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


Candidates must possess a BA or BS. A degree in Biology, Chemistry, Pharmacy or related science field is preferred. Thorough technical knowledge of cGMPs and International regulatory requirements is required. A minimum of 8 years of experience in Quality Assurance, Regulatory Affairs and/or Compliance is required, with significant experience performing GMP audits/support of pharmaceutical manufacturing sites is required, preferably to include a broad range of product experiences. A strong knowledge of the pharmaceutical manufacturing, testing and reporting of regulatory requirements is required. Hands-on experience interacting with regulatory authorities (FDA) is necessary. Experience in communicating effectively to management re-regulatory requirements, issues, and risks is required. Experience interpreting regulatory requirements in the light of current guidance and international regulatory body field activity is required. Experience managing multiple projects, prioritizing and adapting to business needs and understanding of business requirements is required. Prior experience in line management, training or mentoring is preferred. This position will be based 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
Yes - Within Country