Sr. Quality Assurance Manager; Pharma)

Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. 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, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.

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.

This role will apply 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. The role is responsible for evaluating and strengthening contract manufacturing partners’ quality systems, leading quality audits, managing quality agreements, and driving resolution of quality and compliance issues.

Success in this position requires strong cross-functional collaboration with internal stakeholders, including Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics, as well as the ability to influence quality outcomes across a network of third-party manufacturing partners.

• Foster close cooperative relationships with all functions in the company 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.
• Achieve QA operational objectives by acting as the point of contact for quality matters for assigned brands and/or contract manufacturing partners.
• 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 information and opinions to cross-functional teams; 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. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to contract manufacturing partners.
• These include but are not limited to stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports. Ensures that product dossiers are maintained and current.
• Evaluate the effectiveness of contract manufacturing partners quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing contract manufacturing partners response adequacy and timeliness; determining system improvements. Escalates all serious cGMP and regulatory compliance issues to department leadership. Coaches contract manufacturing partners where quality systems are deficient; drive remedial action where necessary.
• Define the 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,…