Vice President, Compliance Job in Horsham, Pennsylvania Us
Janssen Supply Group, LLC, a member of the Johnson Johnson family of companies, is currently recruiting for a Vice President, Compliance, located in Raritan, NJ.
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 RD and Commercial partners to deliver life changing solutions for patients in need.
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 VP, Compliance will drive the development and maintenance of strategic regulatory and quality requirements within the global supply chain and pharmaceutical sector. This individual will partner with senior leaders within the Supply Chain, JJSC Compliance, and across the broader pharmaceutical sector to manage and ensure a strong regulatory product compliance profile. This individual will assure quality and compliance risk is identified and mitigated at all manufacturing sites within the supply chain and across the Pharmaceutical sector. The VP, Compliance will assess overall compliance through the deployment and management of the Global Assessment process. Span of responsibility includes worldwide compliance leadership across all sites in the supply chain network in partner with Compliance leaders in RD and Commercial to ensure end-to-end visibility. This individual will provide leadership to all sites worldwide in the preparations and management of New Product Introductions for regional and global new products. In addition, this individual will proactively identify global risk management and compliance leveraging opportunities. The VP, Compliance will also interact and influence both regulatory authorities and industry organizations in decision making.
Qualifications
A minimum of a Bachelors degree is required. A focused degree in degree/studies in science, engineering, or equivalent is preferred. A minimum of 15 years of relevant industry experience is required. A minimum of 10 years of Quality and Regulatory Compliance experience in a GxP regulated industry is required. Intimate knowledge of the pharmaceutical industry and corresponding regulatory requirements is required. Experience in Pharmaceutical and/or Medical Device industry is required. Strong knowledge of quality and compliance in a regulated manufacturing environment is required. Understanding of requirements for compliant drug manufacture, including facilities, equipment, documentation, testing, and product flow is preferred. Thorough understanding of how regulatory bodies approach inspections and how to respond to FDA observations is required. Working knowledge of New Drug Regulations and GxP/Quality System Regulations is required. Proven experience in a project management role is preferred. Experience with international regulatory requirements associated with the programs supported by a centralized compliance group is preferred. People management experience is also preferred. Strong financial acumen and business planning skills are 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 interpersonal and technical skills are required to facilitate collaborations between Enterprise, sector and operating company management. Proven experience driving results to established timelines and remaining focused under ambiguous and complex situations is required. Strong consultant and leadership skills are required. The ability to quickly and effectively develop succinct regulatory strategies to allow the business to meet its objectives while balancing the need to meet the spirit and intent of worldwide regulations is required. The ability to quickly respond to complex emerging issues and continually adjust and revise to meet local market needs is also required.
This position can be located in Raritan, NJ or Horsham, PA and may require up to 30% domestic and international travel, with higher peaks depending on the business needs.
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