Global Compliance Lead
1 week ago
Global Compliance Lead - Global Drugs, DS/NHP and Cosmetics (Remote) page is loaded
Global Compliance Lead - Global Drugs, DS/NHP and Cosmetics (Remote) Apply locations USA, Remote time type Full time posted on Posted 2 Days Ago job requisition id RA collective energy and ambition. A place where you can make a real difference.
We're a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
Reports To : Global Compliance & QMS Head
Role Accountabilities and Responsibilities :
- Support the C&D Drug, Dietary Supplement/NHP and Cosmetic Auditing & inspection program, ensuring compliance with applicable regulations and standards, in accordance with the business strategy.
- Supports regulatory agency audits globally (FDA, HC and International Authorities) and certifying bodies (USP, UL) which includes inspection preparation, inspection conduct and inspection responses for all medical devices globally.
- Act as the Business Representative for C&D Entities with the Certifying Bodies
- Supports the Global Quality Event Management Process for drugs, dietary supplements/NHP and cosmetics related events
- Provides strategic guidance on drugs, dietary supplements/NHP and cosmetics elements of the QMS
- Manages day-to-day compliance related questions and issues
- Coordinates drugs, dietary supplements/NHP and cosmetics SPOCs assessments of new or revised regulations and standards in support of the Global Surveillance Program
- Special projects and other duties as assigned (remediation)
Education and Experience:
- BS/MS degree in Science or Engineering from accredited institution in related field
- Minimum of combined ten years' experience in drugs and dietary supplements/NHP; including quality assurance, regulatory compliance, and/or R&D
- Experience leading Health Authority audits, both front room and back room, with demonstrated proficiency in successful audit outcomes
- Experience working in an inclusive environment and can effectively collaborate within a global organization
Skills and Competencies:
- Excellent knowledge of regulations governing drugs, dietary supplements/NHP and cosmetics, specifically regulations in U.S., Canada, UK, Europe and Australia
- Excellent leadership and influence skills, with both technical and non-technical partners
- Ability to handle ambiguity and complex situations
- Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude
- Ability to think strategically and to translate strategy into action plans
- Ability to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team player
- Ability to work with all levels of management and build relationships across disciplines
- Excellent communication and presentation skills
#piq
#LI-Remote
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture visit us atChurch & Dwight is a world-leader in household and personal care products. Our global brands include ARM & HAMMER, Batiste, OxiClean, Trojan, XTRA, Nair, First Response, Spinbrush, Orajel, vitafusion, Li'l Critters, Water Pik and FLAWLESS. Founded in 1846, we have operations globally and are listed in the S&P 500.
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