Sr. Quality Assurance Manager

Job Summary

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 medical device and OTC drug product portfolio.

Major Responsibilities/Activities

• Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance.
• Oversee the application of risk management (ISO 14971) and design controls throughout the medical device product lifecycle.
• Evaluate and strengthen contract manufacturing partners’ quality systems, leading quality audits, managing quality agreements, and driving resolution of quality and compliance issues.
• 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.
• 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.
• Define the quality obligations and responsibilities of contract manufacturing partners by preparing, negotiating, and reviewing Quality Agreements.
• Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as Stability, Complaints, Nonconformance Reports, Deviations, Investigations, CAPA for Annual Product Reviews.

Qualifications

• Minimum of a Bachelor's degree in scientific discipline.
• 8+ years of Quality Assurance experience within medical devices and/or pharmaceutical manufacturing environments.
• Knowledge of FDA 21 CFR Parts 211 and 820, FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable medical device and pharmaceutical quality requirements.
• Experience supporting medical device quality systems, design controls, and risk management activities is preferred.
• Experience with leading and managing cGMP audits.
• Demonstrated sound decision-making process and scientific problem-solving capabilities based on facts, data, and the application of 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 details.
• Strong interpersonal and communication skills to effectively work with people at all levels.
• Excellent organizational skills with ability to handle changing priorities in a fast-paced environment and able to adjust workload based on changing priorities.
• Ability to work in a team environment as well as independently with minimal supervision.
• Proficient with Microsoft Office products including Word, Excel, and Power Point.