A 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 BodiesSupports the Global Quality Event Management Process for drugs, dietary supplements/NHP and cosmetics related eventsProvides strategic guidance on drugs, dietary supplements/NHP and cosmetics elements of the QMSManages day-to-day compliance related questions and issuesCoordinates drugs, dietary supplements/NHP and cosmetics SPOCs assessments of new or revised regulations and standards in support of the Global Surveillance ProgramSpecial projects and other duties as assigned (remediation)Education and Experience:
BS/MS degree in Science or Engineering from accredited institution in related fieldMinimum of combined ten years’ experience in drugs and dietary supplements/NHP; including quality assurance, regulatory compliance, and/or R&DExperience leading Health Authority audits, both front room and back room, with demonstrated proficiency in successful audit outcomesExperience working in an inclusive environment and can effectively collaborate within a global organizationSkills and Competencies:
Excellent knowledge of regulations governing drugs, dietary supplements/NHP and cosmetics, specifically regulations in U.S., Canada, UK, Europe and AustraliaExcellent leadership and influence skills, with both technical and non-technical partnersAbility to handle ambiguity and complex situationsStrong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitudeAbility to think strategically and to translate strategy into action plansAbility to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team playerAbility to work with all levels of management and build relationships across disciplinesExcellent communication and presentation skills#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 at http://www.churchdwight.com/