Fda Inspector Jobs in Raleigh, NC (NOW HIRING)

Senior Manager, Quality Assurance

Description:

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.

Key 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 ability to influence cross functional and senior stakeholders.

• ASQ certifications desirable, Business coursework, Six Sigma Teachings, desirable

Knowledge & Skills:

• Experience working in a global organization with third-party manufacturing networks.
• Prior experience acting as the Quality lead or SME for OTC programs during regulatory inspections.
• OTC regulatory and quality expertise
• Strong leadership and decision-making skills
• Excellent written and verbal communication
• Risk based thinking and attention to detail
• Ability to operate effectively in a matrixed, global environment

Revlon is unable to sponsor or transfer employment visas for this role; candidates must be legally authorized to work in the United States without current or future visa support.

The base pay range for this position is $105,000.00 - $130,000.00 / year; however base pay offered may vary depending on skills, experience, job-related knowledge, and geographic location. Certain positions may also be eligible for short-term incentives as part of total compensation.

Employees (and their families) are eligible for medical, dental, and vision benefits. Employees are covered by the company-paid basic life insurance policy and company-paid short-term disability insurance (the benefit commences upon hire and allows for a portion of base salary for up to 26 weeks if you are disabled). Other benefits offered to employees include but are not limited to the following: long-term disability, supplemental life insurances, flexible spending accounts, critical illness insurance, group legal, identity theft protection, etc. Employees are also able to enroll in our 401k Retirement Savings Plan.

Employees will also receive 3 weeks of vacation, pro-rated based on date of hire for the 1st year of employment and twelve paid holidays throughout the calendar year. Vacation will depend on role.

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