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Senior Manager, Quality Assurance

External
revloncorporate logoRevloncorporate · Kenilworth, NJ
Full-timeOn-site2w ago
AuditingComplianceCross-functional CollaborationDocumentationLeadershipRisk Management
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About the role

The Senior Quality Manager, OTC Program is responsible for the leadership, governance, and continuous improvement of the company's Over-the-counter (OTC) quality program for cosmetic and OTC products. This role ensures full compliance with applicable FDA regulations and internal quality standards across product development, manufacturing, testing, release, and post market activities. The position serves as the Quality subject matter expert for OTC regulatory requirements and provides strategic and operational leadership to ensure consistent implementation of OTC program guidelines across internal sites and third-party manufacturers.

Responsibilities

  • OTC Quality Program Leadership
  • Own and continuously improve OTC Quality Program guidelines, standards, and governance aligned with FDA requirements (21 CFR Parts 201, 210, 211, as applicable) and Health Canada requirements to ensure compliance and inspection readiness.
  • Serve as the primary Quality point of contact and SME for OTC regulatory/compliance matters, including MoCRA rollout and regulatory milestone execution.
  • Quality Compliance & Oversight
  • Ensure OTC products are manufactured, tested, labeled, released, and distributed in compliance with FDA requirements and internal QMS standards, providing lifecycle oversight (change control, deviations, investigations, CAPAs, and product disposition).
  • Lead or support FDA inspections and internal/external audits for OTC products, ensuring timely closure of observations.
  • Quality Systems Integration
  • Integrate OTC requirements into the QMS (validation, supplier quality, complaints, stability, documentation) and define/oversee validation strategies for OTC products, processes, equipment, and computerized systems.
  • Partner with QC, Regulatory Affairs, Manufacturing, R&D, and Supply Chain to apply OTC quality requirements consistently.
  • Third-Party Manufacturing & Supplier Quality
  • Provide quality oversight to third-party manufacturers, laboratories, and suppliers supporting OTC products, including qualification, auditing, and performance monitoring to maintain compliance.
  • OTC Drug Stability Program
  • Lead a team of individual contributors to ensure compliance with annual and accelerated stability testing, including authoring, review, and approval of stability protocols and final reports.
  • Leadership & Cross-Functional Collaboration
  • Lead, mentor, and develop team members supporting OTC activities, and provide training/guidance to cross-functional teams on OTC quality and regulatory expectations; reinforce a culture of compliance and accountability.
  • Influence senior stakeholders to enable timely, compliant, risk-based decisions.
  • Risk Management & Continuous Improvement
  • Identify OTC quality/compliance risks, monitor regulatory trends and enforcement activity, assess impact, and implement effective mitigation plans and program updates.
  • Lead continuous improvement to strengthen compliance, efficiency, and inspection readiness.
  • 25% travel required (mainly in USA)
  • Required Competencies, Skills & Experience
  • Bachelor's degree in chemistry, Pharmacy, Life Sciences, Engineering, or related scientific discipline.
  • Minimum 7+ years of experience in Quality Assurance or Quality Management within the cosmetic, pharmaceutical, or consumer health industry.
  • Strong, demonstrated knowledge of FDA OTC regulations and quality system requirements.
  • Proven experience supporting FDA inspections and managing OTC related‑ quality programs.
  • Demonstrated leadership skills with the a

Benefits

Health insuranceRemote work options

Additional Information

At Revlon, we create beauty innovations for everyone that inspire confidence and ignite joy every day. Breaking beauty boundaries is in our company's DNA. Since its game-changing launch of the first opaque nail enamel in 1932 (and later, the first long-wear foundation), Revlon has provided consumers with high-quality product innovation, performance, and sophisticated glamour. Elizabeth Arden made waves as a woman-led beauty company in the 1920s. In 1931, Almay became the original hypoallergenic, fragrance-free beauty brand. Today, Revlon resiliently continues its legacy as a leading global beauty company. Our diverse portfolio-which consists of some of the world's most iconic brands and product offerings in color cosmetics, skincare, hair color & care, personal care, and fragrances-is sold around the world through prestige, professional, mass, and direct-to-consumer retail channels. These brands include Revlon, Revlon Professional, Elizabeth Arden, Almay, American Crew, CND, Cutex, Mitchum, Sinful Colors, Creme of Nature, Christina Aguilera, John Varvatos, Juicy Couture, Ed Hardy and more. We honor our heritage, embrace change, and applaud diversity. We champion our employees and celebrate our consumers. We are Revlon, together, transforming beauty. This role is a Hybrid Role: Employees are expected to work from our Kenilworth, NJ office 3 days per week and may work remotely the remaining days Senior Manager, Quality Assurance


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