Quality Assurance and Regulatory Affairs Senior Manager

Remote (United States)

We are Starface

Starface has turned traditional complexion care on its head, as the first to combine efficacy and optimism, making acne an opportunity for self-expression.

Your Impact at Starface

As Starface continues growth in new products and new markets, the Quality Assurance and Regulatory Affairs Senior Manager / Director will be a key enabler to streamline the regulatory affairs and quality functions and processes at Starface. The QA/RA Senior Manager/ Director will report into the VP of Product Development. You are passionate about the beauty and wellness industry, thrive in fast paced environments, and are a generous cross-functional collaborator. You will ensure our existing and new products are compliant, keep our processes on point, and keep up to date on regulatory developments. You will build and roll out our Quality Management System and QA/RA team to ensure our products meet the highest standards and are safe for our customers.

We will count on you to:

Regulatory Affairs Scope:

Work closely with the VP of Product Development to evaluate formula submissions, provide feedback and re-directs, select submissions to be presented back to key stakeholders, and define new products concepts and benchmarks
Compile preliminary regulatory assessments in liaison with safety assessor/consultant and contract manufacturers for all formulas, ingredients, and innovations for all countries of interest before formula approval.
Compile ingredient documentation requirements to ensure compliance with Starface formulation guidelines, supporting product claims and registrations.
Works with regulatory legal representation, external consultants, retailers, distributors to compile, supply or upload documentation (ILs, SDS, COA etc) for new product registrations and regulatory filings.
Liaison to cross-functional management meetings, providing risk-management support, reformulation updates, testing and regulatory advice, as necessary.
Interfaces regularly with key internal (product development, quality, supply chain, legal, packaging)
Maintain partnerships with external contacts (RP, consultants, distributors, contract manufacturers, suppliers, 3rd party regulatory agencies) to ensure quality and safety of all products to meet industry standards.
Keep organization abreast of regulatory changes (e.g., registration requirements, Prop 65, Clean beauty guidelines) and perform duties to ensure compliance.
Ensure new product development lands compliant, and existing products remain compliant.
Conduct reviews and acts as the regulatory gatekeeper for all artwork review, labeling and claims (e.g. labels, websites, inserts, advertisements and/or brochures, etc.).
Works with RP/external consultant to create, collate, and/or Manage PIF documentation for submission to 3rd party regulatory agencies and retail partners. Conducts US-based filings (VCRP, SB 484, etc.)
Create and manage product briefs to finalize concepts, research and define the products feasibility and development parameters
Responsible for researching new ingredients, textures, products and packaging to allow for greater innovation

Quality Assurance Scope:

Responsible for developing and administering the Quality Management System and ensuring the product meets the established standards of quality. Draft quality assurance policies and procedures and responsible for maintaining document management systems.
Interpret and implement quality assurance standards.
Develop, recommend and monitor corrective and preventive actions. Develop and manage Supplier Quality programs.
Evaluate adequacy of quality assurance standards. Devise sampling procedures and directions for recording and reporting quality data. Plan, conduct and monitor testing and inspection of materials and finished products.
Document internal audits and other quality assurance activities. Analyze data to identify areas for improvement in the quality system.
Prepare reports to communicate outcomes of quality activities.
Identify training needs and ensure training for all employees.
Coordinate and host audits, FDA inspections

Who we are looking for

Minimum Bachelor’s Degree or Advanced degree, ideally in basic science, chemistry, toxicology or life sciences
5+ years of experience in the Cosmetic/Personal Care/OTC industry regulatory affairs role, with direct experience in the regulatory requirements of a skincare, cosmetics or personal care innovation stream and in-market product compliance.
5-10+ years of QA experience in Medical Devices or Pharmaceuticals
Experience with the US market and international product registrations and labeling requirements.
Strong knowledge of FDA regulations, cGMP’s, 21 CFR, ISO 13485
Familiarity with technical transfers
Excellent organization skills, ability to prioritize multiple tasks, exceptional attention to detail.
Demonstrated ability to manage multiple projects through strong prioritization and planning
Proven track record of taking ownership and driving results
Interpersonal, communication and presentation skills
Experience with Word, Excel, PowerPoint, Smartsheets and Dropbox
Ability to work in fast-paced, ever-changing, start-up collaborative environment
Willingness to work on administrative tasks and “no task is too small” attitude

SALARY AND BENEFITS:

Remote team
Compensation for this role is $105-170k depending on experience.
Current benefits include:
Access to high-quality health care options, including 100% coverage for employee and spouse
Access to a 401k with 5% employer match
4 weeks of vacation plus 15 paid holidays
5 Days Pet-ternity (Dog or Cat)
Home office stipend

Starface World Inc. is an Equal Opportunity Employer. Starface does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All information provided by the applicant is collected, stored and processed in accordance with the terms of our Privacy Policy