Vice President, Quality Assurance, Regulatory Affairs

📋 Description

• Act as a key member of the leadership team, offering guidance, advice, and insights regarding quality and regulatory compliance across all leadership discussions.

• Spearhead the development and execution of QA/RA strategies, policies, and objectives that align with company goals while fostering growth ambitions.

• Create and implement quality management systems that adhere to FDA guidelines, Unilever standards, and the best practices within the industry.

• Oversee RA activities to guarantee regulatory compliance for both existing products and new launches, which encompass ingredient evaluations, label and supplement facts panel assessments, claims substantiation, product certifications, and marketing asset reviews.

• Collaborate with Product, Supply Chain, and other departments to ensure timely regulatory submissions and comprehensive compliance.

• Build and lead a high-performing QA and RA teams, scaling resources and capabilities to meet business demands effectively.

• Represent the organization during audits, inspections, and regulatory meetings, offering leadership and expertise.

• Work cross-functionally to support innovation, supplier management, risk assessments, and product disposition while ensuring adherence to regulatory requirements.

• Engage in external policy and advocacy efforts to create, sustain, and safeguard the business.

• Establish and maintain a supplier qualification and monitoring program backed by thorough quality agreements.

• Ensure the distribution of compliant products that fulfill our brand promise and meet consumer expectations.

• Remain updated on FDA and industry compliance standards, legislation, and trends, recommending actions to maintain ongoing compliance and audit preparedness.

• Utilize data and metrics to promote continuous improvements.

⛳️ Requirements

• 15 - 20+ years of quality leadership experience within an FDA regulated industry (experience in Dietary Supplements is mandatory).

• Bachelor’s degree in chemistry, biology, or a related scientific discipline; an advanced degree is highly preferred.

• Comprehensive knowledge of GMPs under 21 CFR Parts 101, 110, 111, and 117 (mandatory experience with Dietary Supplement regulations).

• Proven experience managing gummy qualifications and quality operations in a production environment is essential.

• Prior involvement in supporting RA review activities concerning ingredients, claims, and certifications is required.

• Hands-on experience with hosting and managing regulatory audits and subsequent follow-ups.

• Excellent verbal and written communication skills, with the capability to influence a culture of quality.

• Proven ability to lead and motivate high-performing teams, effectively delegate tasks, and promote collaboration.

• Strong analytical, strategic thinking, and problem-solving capabilities, with the ability to prioritize tasks in a fast-paced environment.

• Experience in developing and implementing QMS programs and regulatory frameworks that facilitate organizational growth, innovation, and compliance.

• Advanced understanding of risk management principles, root cause analysis, and corrective and preventive action processes (CAPA).

🏝️ Benefits

• An opportunity to collaborate with a highly intelligent, inspiring, and exceptionally enjoyable team.

• We cover 100% of the premiums for employee-only medical, dental + orthodontics, and vision insurance.

• Enjoy 4 weeks of PTO, paid holidays, and 12 Mental Health Days annually.

• Receive 100% Paid parental leave, along with Fertility and Adoption Benefits.

• Participate in an Annual Bonus program.

• Benefit from a 401(k) plan with Employer Match.

• Experience hybrid work arrangements, wellness initiatives, and cell phone stipends.

• Access to free products.

• And much more!