HireDiversity

Raritan, NJ, US

Director, Global Pharmaceutical Regulatory Compliance-0309120724

Description

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need. Janssen Supply Group, LLC is seeking a Director, Global Pharmaceutical Regulatory Compliance based in the U.S. or Puerto Rico.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

The Director, Global Pharmaceutical Regulatory Compliance will provide leadership for site development, deployment and maintenance of strategic regulatory and quality requirements within the pharmaceutical sector. This individual will assure compliance programs are implemented and maintained at the applicable and assigned sites in the Americas supply chain. This individual will work with business partners to mitigate compliance risk at responsible manufacturing sites. The Director, Global Pharmaceutical Regulatory Compliance will assist sites in preparing for and management of Pre-Approval Inspections for new products. This individual will proactively identify and prioritize compliance risks at assigned sites or across the supply chain in general. This individual will partner with Compliance peers within the group and with Enterprise as appropriate for consistency and leveraging opportunities. The Director, Global Pharmaceutical Regulatory Compliance will help manage the escalation and resolution of Quality and Compliance issues. This individual will also make decisions regarding the applicability of cGMP and other Health Authority regulations to sites and distribution center operations.

Qualifications


A minimum of a Bachelors degree is required. A focused degree in Biology or Chemistry is preferred. A minimum of 10 years of relevant industry experience is required. A minimum of 5 years of Quality and Regulatory Compliance auditing experience in a GxP regulated industry is required. Experience in Pharmaceutical and/or Medical Device industry is preferred. Previous auditing experience and understanding of compliance programs such as escalation, advisory notices, field actions and inspection readiness is required. Experience interpreting regulatory requirements in the light of current guidance and international regulatory body field activity is required. Experience in communication of requirements and regulatory issues is required. Hands-on experience interacting with regulatory authorities is required. Experience as a health authority or regulator is desirable. The position requires employee to be fluent in English and must have excellent ability to write in English. The ability to fluently to speak, read and write in Spanish is preferred.

An understanding of requirements for compliant drug manufacture including facilities, equipment, documentation, testing, and product flow is preferred. Proven experience managing projects is required. Experience with international regulatory requirements associated with the programs supported by a centralized compliance group is preferred.

The ability to be detail and goal oriented, focused on team work and the customer, prioritize and adapt to business needs is required. Excellent written and verbal communication, influencing, and negotiation skills are required to inspire trust and quickly build credibility within the Quality and Compliance community. Strong consultant and leadership skills are required.

This position can be located in Raritan, NJ, Horsham, PA, Gurabo, Puerto Rico or Manati, Puerto Rico and may require up to 40% domestic and international travel, with higher peaks depending on the business needs.

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-New Jersey-Raritan
Organization: JANSSEN SUPPLY GROUP, LLC (6046)