Full-Time

Product Quality & Regulatory Director

Posted on 9/26/2024

Face Reality Skincare

Face Reality Skincare

51-200 employees

Acne treatment products and professional training

Education
Consumer Goods

Compensation Overview

$160k - $180kAnnually

+ Yearly Bonus + Full Benefits

Senior, Expert

No H1B Sponsorship

Danville, CA, USA

Hybrid position requiring on-site work in Danville Tuesdays - Thursdays.

Category
Legal
Risk & Compliance
Legal & Compliance
Required Skills
Marketing
Customer Service
Requirements
  • 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 solutions
Responsibilities
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Oversee the 'Responsible Person' duties for the brand in the US as per MoCRA, and liaison for future global requirements such as the EU; Stay abreast of changing regulations and industry trends, advising the company on necessary adjustments to maintain compliance.
  • Ensure final formulas and ingredients are compliant in all current and planned regions of distribution.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Face Reality Skincare

Face Reality Skincare

View

Face Reality Skincare specializes in acne treatment solutions for individuals and skincare professionals. The company offers a range of effective, cruelty-free skincare products designed to clear acne, achieving a success rate of over 90% in 3-4 months. Additionally, it provides training programs for estheticians to become certified Acne Experts, enhancing their skills and business growth. Face Reality Skincare stands out by combining high-quality products with professional training and support, aiming to empower both clients and skincare professionals.

Company Stage

Growth Equity (Venture Capital)

Total Funding

N/A

Headquarters

San Leandro, California

Founded

2005

Simplify Jobs

Simplify's Take

What believers are saying

  • Face Reality's revenue has quadrupled since 2020, expected to exceed $30mm in 2023.
  • Partnership with Paige DeSorbo enhances brand visibility during Acne Awareness Month.
  • Exclusive distribution of Preston Comedone Rxtractor® strengthens their professional acne brand position.

What critics are saying

  • Partnership with Paige DeSorbo may not align with Face Reality's target demographic.
  • New supplements could face regulatory scrutiny or consumer skepticism.
  • Strategic shifts from new CFO and Board Member may disrupt current operations.

What makes Face Reality Skincare unique

  • Face Reality Skincare offers a dual approach: premium products and specialized training.
  • Their products boast a 90% success rate in clearing skin within 3-4 months.
  • Face Reality fosters a community providing business tools and insights for skincare professionals.

Help us improve and share your feedback! Did you find this helpful?

INACTIVE