Senior Manager, Quality Assurance, Regulatory & Compliance

Job Description

Job Description

POSITION DETAILS 

Job Title: Senior Manager, Quality Assurance, Regulatory & Compliance Location: Yonkers, NY / Onsite / Hybrid 

Reports To: Sr. Director, Supply Chain 

Direct Reports: None (Individual Contributor) 

Status: Exempt 

Compensation: $120,000 to $130,000 

ABOUT THE ROLE 

We are seeking an experienced and highly analytical Senior Manager, Quality Assurance, Regulatory & Compliance to lead our global quality and compliance functions. As a rapidly growing hair care brand, we require a hands-on leader to ensure our products meet the highest standards of safety, efficacy, and legal compliance across all global markets. 

In this role, you will own the end-to-end quality control lifecycle, from raw material qualification to finished goods distribution, while serving as our internal subject matter expert for global cosmetic regulations. You will play a critical role in managing our compliance with the Modernization of Cosmetics Regulation Act (MoCRA) in the US, as well as maintaining active registrations and compliance in the EU, UK, and other international markets. 

KEY RESPONSIBILITIES 

Global Regulatory Compliance 

● MoCRA & FDA Leadership : Serve as the designated "Responsible Person" (or primary liaison) to ensure full compliance with MoCRA requirements, including facility registrations, product listings, safety substantiation, and fragrance allergen disclosures. 

● International Market Registrations: Lead and maintain product registrations across global portals, including the EU Cosmetic Products Notification Portal (CPNP), UK Submit Cosmetic Product Notification (SCPN), and Health Canada. 

● Claims Substantiation & Labeling : Serve as the definitive regulatory authority for product marketing and packaging. Collaborate with Marketing, Legal, and Product Development to ensure all packaging artwork, ingredient lists (INCI), and warnings comply strictly with FDA and international standards. Maintain ownership of the testing matrix and claims substantiation repository, establishing a mandatory QA/Regulatory approval gate for all technical data prior to market release. 

● Adverse Event Management: Oversee the adverse event reporting system; manage serious adverse event reporting timelines, maintain recordkeeping, and ensure root-cause investigations are conducted.

● Regulatory Intelligence: Monitor shifting regulatory landscapes (e.g., Prop 65, volatile organic compounds (VOC) restrictions for aerosols, state-level bans) and proactively update internal formulations and policies to mitigate risk. 

End-to-End Quality Control & Assurance 

● CMO & Supplier Management: Audit, qualify, and manage third-party contract manufacturing organizations (CMOs), raw material suppliers, and packaging vendors. Ensure alignment with GMP (Good Manufacturing Practices) and ISO 22716 standards. 

● Product Testing & Release: Oversee stability, compatibility, and microbiological testing protocols for new and existing hair care formulations. Review and approve Certificates of Analysis (COAs), batch records, and retain samples 

● Packaging Compatibility & Structural Testing: Lead Package Compatibility Testing (PCT), E&L studies, and structural assessments (e.g., torque, seal, barrier). Ensure all packaging meets ISTA transit standards and maintains integrity with complex hair care formulations like aerosols and surfactants. 

● Issue Resolution: Lead root-cause analysis, corrective and preventive actions (CAPA), and Out of Specification (OOS) investigations. Make critical disposition decisions regarding product approvals, quarantines, or rejections. 

● Quality Management Systems (QMS): Build, scale, and maintain internal QMS documentation, including Standard Operating Procedures (SOPs), finished product specifications, and quality agreements with external partners. 

Cross-Functional Leadership 

● New Product Development (NPD): Act as the regulatory and quality gatekeeper during the R&D and commercialization phases. Advise on ingredient restrictions and formulation safety. 

● Team Development: Manage and mentor quality coordinators or specialists. Provide training to cross-functional teams (Operations, Customer Service) on regulatory requirements and quality standards. 

REQUIRED QUALIFICATIONS 

● Education: Bachelor’s degree in Chemistry, Chemical Engineering, Biology, Regulatory Affairs, or a related scientific discipline. Master’s degree preferred. 

● Experience: 7–10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the CPG industry, specifically in cosmetics, personal care, or hair care.

● Regulatory Expertise: Deep, demonstrated understanding of US FDA cosmetic regulations (MoCRA), EU CosReg, UK regulations, and global compliance frameworks. 

● Quality Systems: Strong background in cGMP, ISO standards (e.g., ISO 22716), ISTA transit testing, and handling FDA inspections or third-party audits. 

● Hair Care Knowledge: Familiarity with hair care specific formulation challenges, including emulsions, surfactants, aerosols (VOC compliance), and clinical testing for hair claims. 

● Skills: Exceptional analytical, problem-solving, and cross-functional communication skills. Ability to thrive in a fast-paced environment and balance risk-management with commercial business goals. 

PREFERRED EXPERIENCE 

● eQMS Implementation: Proven experience selecting, implementing, or migrating electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or TrackWise, as well as integrating quality modules within ERPs like NetSuite or SAP. 

● Advanced Formulation Expertise: Direct experience managing compliance and quality control for Over-the-Counter (OTC) monographs (e.g., dandruff shampoos, minoxidil hair growth treatments), continuous mist aerosols, or professional-grade salon chemical treatments. 

● Retailer & Clean Beauty Standards: Deep understanding of specialized retailer compliance frameworks, such as "Clean at Sephora," Target Clean, or Credo Beauty guidelines, and experience managing the formulation and documentation required to meet them. 

● Professional Certifications: Active Regulatory Affairs Certification (RAC) or American Society for Quality (ASQ) certifications, such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality (CMQ/OE). 

● Sustainability & ESG: Experience guiding quality and regulatory practices for sustainability initiatives, such as achieving B-Corp certification, managing PCR material tracking, or navigating extended producer responsibility (EPR) packaging laws.

SCOPE OF DECISION-MAKING 

Autonomous Decisions (Direct Authority) 

● Product Disposition: Final authority to release, quarantine, or reject finished goods and raw materials based on test results, COAs, and quality standards. 

● Compliance Sign-Off: Sole approval authority on ingredient lists (INCI), regulatory packaging warnings, and safety substantiation prior to printing or market launch. 

● Supplier Qualification: Authority to approve, conditionally approve, or disqualify contract manufacturers (CMOs), packaging vendors, and raw material suppliers based on audit results and cGMP compliance. 

● CAPA & Investigations: Direct control over resolving Out of Specification (OOS) investigations, determining root causes, and enforcing Corrective and Preventive Actions (CAPAs) with internal teams and external vendors. 

● SOP Enforcement: Authority to implement, update, and enforce Quality Management System (QMS) policies and standard operating procedures across the organization. 

Collaborative & Escalated Decisions (Advisory Role) 

● Product Recalls & Withdrawals: Lead the initial risk assessment and data gathering for potential safety issues, but escalate final recall execution and communication strategies to Executive Leadership and Legal. 

● New Market Entry: Advise the Executive team on the regulatory feasibility, costs, and timeline of entering new international markets (e.g., reformulations needed, registration hurdles). 

● Marketing Claims: Partner with Legal and Marketing to negotiate and finalize high-risk product claims (e.g., "clinically proven," "hair growth"), balancing commercial goals with regulatory constraints. 

● Major Capital Expenditures: Recommend investments in enterprise quality software (eQMS) or third-party laboratory partnerships for executive budget approval. 

People Management: None