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Product Quality & Regulatory Director - Danville California
Company: Tbwa Chiat/Day Inc
Location: Danville, California
Posted On: 11/19/2024
Face Reality Skincare was created with one goal: to give people clear skin and confidence. With over 50 million people managing the physical and emotional toll of acne, we made it our mission to develop an effective way to achieve clear skin through adaptive, expert guidance by trained estheticians and premium formulas that use only tested, safe ingredients. We are dedicated to giving not just real results but celebrating people and their skin at every part of their journey.Our Core ValuesOur supportive business model ensures that everyone has a clear path to success and growth. We foster an inclusive space in which people are valued for who they are and are encouraged to collaborate to see goals fully realized. Fostering an open, honest culture gives us the opportunity to achieve greater trust internally and externally. Remaining flexible and adaptive allows us to remain responsive to the ever-changing world. Doing right, even if it is difficult, is of the utmost importance.Product Quality & Regulatory DirectorPosition OverviewThe Product Quality & Regulatory Director will play a pivotal role in ensuring the highest standards of product quality and regulatory compliance for our skincare and cosmetic products. This leadership position requires a deep understanding of quality assurance and control processes, US and global regulatory requirements, claims substantiation, risk management, and the ability to collaborate and communicate across departments to ensure that our products meet required compliance and brand standards. The ideal candidate has a strong background in OTC and cosmetics, and has the ability to be proactive not just reactive, to think strategically but work hands-on, to focus on partnering not just policing, and is dedicated to maintaining and enhancing our brand's reputation for excellence. This is a hybrid position where you will work on-site in Danville Tuesdays -Thursdays and remotely Mondays and Fridays. *Please note we are not in a position to sponsor Visa's at this time.Responsibilities and Essential Functions - Quality Leadership: Develop and implement quality assurance strategies, policies, and procedures. Manage all product quality aspects, including quality audits, product complaint reporting, undesirable event processes, and maintaining formula and packaging quality documents and specifications.
- Quality Management: Establish quality standards and Finished Good Specifications for each product and related components, working with Product Development, R&D and Supply Chain Operations; Oversee batch and finished good review and release; Work closely with the Customer Service team to identify and rapidly address customer product concerns, complaints and adverse events; Manage monthly/quarterly quality reporting on each product and related components; Manage quality issue investigations and non-conformance management, conducting detailed root cause analyses on compliance issues.
- Process Development & Improvement: Build on existing QA and QC processes, review specifications, set up appropriate testing and collaboration protocols, and continually improve total delivered quality; Lead cross-functional teams to resolve quality issues and improve quality management systems (QMS); Support R&D in root cause analysis and manufacturing process and/or material improvements when needed.
- Risk Management: Handle risk assessment, identify safety concerns, and implement preventive measures to avoid potential product issues; Develop traceability procedures for finished goods, packaging, and raw materials, monitor product safety, and ensure the product recall program is well tested and implemented.
- Vendor Quality Audits: Conduct vendor quality audits as needed to ensure adherence to regulatory requirements and brand standards; Manage relationships with contract manufacturers, ingredient suppliers, and packaging suppliers to ensure all product quality meets company and industry standards.
- Regulatory Compliance: Own the product regulatory function for the brand, ensuring compliance with US and global regulations. Manage all regulatory workstreams for current regions and continuous changes in future regions where the brand is sold. Stay abreast of changing regulations and industry trends, advising the company on necessary adjustments to maintain compliance.
- Ingredient and Formula Compliance: Ensure final formulas and ingredients are compliant in all current and planned regions of distribution.
- Packaging and Claims Substantiation: Oversee compliance with commercial, advertising, and labeling laws in all regions where the brand is distributed (currently US only); Review product packaging/labeling and consumer marketing materials; Ensure that all product claims (e.g., efficacy, safety, "free-from" statements) are scientifically substantiated and compliant; Maintain a claims approval process, tracking feedback and changes to claims as needed; Qualify proposed claims and marketing/education copy, maintaining an approved claims database. Manage all third-party certifications related to product claims and compliance. Work with outside legal counsel or regulatory agencies when deemed appropriate.
- Registration: Oversee the preparation and submission of US cosmetic and OTC regulatory filings, product registrations, and technical documentation. Currently US only, but must be well-breadth in global requirements for future international distribution. Manage international registration requirements and process; Coordinate the procurement of notarized, and/or legalized GMP Certificates, Certificates of Free Sale, and other documents as needed for international distribution.
- Documentation Management: Lead master formula documentation, working with R&D to compile all necessary formula, testing, efficacy, and ingredient compliance paperwork from manufacturers, vendors, testing partners, and raw material suppliers. Own and maintain documentation updates and change control.
- Cross-Functional Collaboration: Partner with PD/R&D, Operations Supply Chain, Customer Service, and Marketing teams to ensure seamless product launches, and to ensure new and existing products meet quality standards and regulatory requirements; Partner closely with external manufacturing partners to align on quality management systems and ensure compliance with brand standards.
- Leadership & Development: Assess, build and manage quality and regulatory team members as appropriate with the growth of the company; Coach and train as needed on all aspects of quality and compliance, including development planning and performance evaluation, to create a culture of quality within the team.Requirements and Qualifications:
- Bachelor's degree in Chemistry, Biology, Cosmetic Science, or a related field. An advanced degree (e.g., Master's or PhD) is preferred
- Minimum of 10 years of experience in quality assurance and regulatory affairs within the skincare, cosmetics, or personal care industry
- Strong leadership and communication skills, with the ability to influence and collaborate across departments, while also being able to work hands-on
- Experience with quality management systems (QMS), risk management, and continuous improvement methodologies.
- Deep knowledge of global cosmetic regulations, including FDA, EU Cosmetic Regulation, REACH, and others.
- Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously
- Excellent problem-solving skills, with the ability to quickly analyze complex issues and develop effective solutionsPhysical Requirements:
- Must be able to lift and carry objects weighing up to 25 pounds
- Ability to stand, walk and bend for extended periods
- Excellent hand-eye coordination and manual dexterity
- Ability to perform repetitive tasks with accuracy and attention to detail
- Must be able to communicate effectively in verbal and written form
- Comfortable lifting, pushing, and pulling equipment and materials
- Comfortable using a computer, keyboard, and mouseAt Face Reality you will have an opportunity to:
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