Sr. Quality Assurance Manager (Pharma)

Prestige Consumer Healthcare focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to improve the lives of our customers. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are one of the largest independent providers of over-the-counter products in North America, constantly improving and creating products that match the evolving lifestyles and needs of people and families.

About the role

The Sr. Manager, Quality Assurance, is a key member of the Quality & Regulatory Affairs team responsible for ensuring the quality, compliance, and continuous improvement of Prestige Consumer Healthcare's OTC drug and dietary supplement product portfolio. This role serves as the primary Quality Assurance lead for assigned brands and contract manufacturing partners, providing strategic quality oversight throughout the product lifecycle—from new product development and commercialization through ongoing manufacturing and post-market support. The role applies Quality Assurance, cGMP, and risk management expertise to support existing products and new product introductions while ensuring compliance with applicable FDA regulations, ISO standards, and other global quality requirements.

Responsibilities

• Foster cooperative relationships with all company functions relative to quality and GMP compliance.
• Establish, implement, and maintain comprehensive policies and Standard Operating Procedures (SOPs) that comply with FDA 21 CFR Part 111, 210, and 211.
• Act as the point of contact for quality matters for assigned brands and/or contract manufacturing partners to achieve QA operational objectives.
• Lead QA strategy for assigned brands by studying product requirements; analyzing options for product stability and process validation; recommending, preparing, and presenting corrective action plans; contributing to cross-functional teams; and preparing implementation plans and timelines.
• Drive continuous improvement initiatives across contract manufacturing partners' quality systems to enhance compliance, efficiency, and product quality.
• Identify and mitigate quality and compliance risks through the application of risk management principles and proactive quality oversight.
• Provide strategic quality leadership and recommendations to cross-functional teams supporting product development, commercialization, and lifecycle management.
• Support new product introductions from a Quality perspective.
• Review and approve documentation associated with the introduction or transfer of new or existing products to contract manufacturing partners, including stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging, and cleaning validation protocols and reports.
• Ensure product dossiers are maintained and current.
• Evaluate the effectiveness of contract manufacturing partners' quality systems by leading cGMP compliance audits, issuing audit reports, managing responses, and determining system improvements.
• Escalate serious cGMP and regulatory compliance issues to department leadership.
• Coach contract manufacturing partners where quality systems are deficient and drive remedial action where necessary.
• Define quality obligations and responsibilities of contract manufacturing partners by preparing, negotiating, and reviewing Quality Agreements.
• Provide leadership, guidance, and influence across cross-functional teams and external manufacturing partners to ensure quality, compliance, and business objectives are achieved.
• Assure the quality of commercial product by reviewing and approving contract manufacturing partners' change controls, deviations, nonconformances, and out-of-specification investigations.
• Initiate and conduct internal change controls, planned deviations, and investigations where applicable.
• Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as Stability, Complaints, Nonconformance Reports, Deviations, Investigations, and CAPA for Annual Product Reviews.
• Maintain confidentiality to protect the organization’s competitiveness.
• Stay current with professional and technical knowledge by tracking regulatory developments, attending workshops, reviewing publications, establishing networks, benchmarking practices, and participating in professional societies.
• Accomplish organizational goals by accepting ownership for new and different requests and exploring opportunities to add value.

Requirements

• Minimum of a Bachelor's degree in a scientific discipline.
• 8+ years of Quality Assurance experience within OTC drugs and dietary supplements and/or pharmaceutical GMP manufacturing environments.
• Knowledge of FDA 21 CFR Parts 111, 210, and 211 and applicable pharmaceutical quality requirements.
• Experience leading and managing cGMP audits.
• Demonstrated sound decision-making and scientific problem-solving capabilities based on facts, data, and risk management principles.
• Proven track record of managing multiple responsibilities with a consistent sense of urgency.
• Excellent written and verbal communication skills with superior attention to detail.
• Strong interpersonal skills to effectively work with people at all levels.
• Excellent organizational skills with the ability to handle changing priorities in a fast-paced environment.
• Ability to work in a team environment as well as independently with minimal supervision.
• Proficient with Microsoft Office products including Word, Excel, and PowerPoint.
• Ability to travel 20% (via car, plane, rail).

Skills

• Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
• Ability to calculate figures such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Ability to apply concepts of basic algebra and geometry.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

Physical Demands

• Regularly required to sit and frequently required to talk or hear.
• Occasionally required to stand, walk, use hands to finger, handle, or feel, reach with hands and arms, stoop, kneel, crouch, or crawl.
• Must occasionally lift and/or move up to 10 pounds.
• Specific vision abilities required include close vision and the ability to adjust focus.

Work Environment

• The noise level in the work environment is usually moderate.

Pay

Compensation range: $150,000.00 - $175,000.00 annually.

Schedule

• Hybrid work schedule: Tuesdays, Wednesdays, and Thursdays in the Tarrytown office; remote on Mondays and Fridays.
• 40 hours per week.

Applicants must be authorized to work for any employer in the U.S. No sponsorship is available for employment visas at this time.