Senior Manager, Quality Assurance (Lynchburg, VA)

Prestige Brands Holdings - Lynchburg, VA

Full-time - Senior

Lynchburg, VA

Merchant Wholesalers, Nondurable Goods

About the position

The QA Sr. Manager will oversee the Quality Assurance group, ensuring that all OTC, ANDA/NDA and cosmetic products meet the highest standards of quality and compliance with regulatory requirements. This role involves managing QA processes, supporting regulatory inspections, leading audits, and implementing quality systems to maintain product integrity and safety.

Responsibilities

• Manage and mentor the QA team, fostering a culture of quality and continuous improvement.
• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with regulatory standards (e.g., FDA, GMP).
• Ensure all manufacturing processes comply with local and international regulations and guidelines.
• Lead internal and external audits, including regulatory inspections. Prepare and present audit reports and follow up on corrective actions.
• Oversee the creation, review, and approval of quality-related documents, including SOPs, batch records, and validation protocols.
• Develop and conduct training programs for staff on quality standards, procedures, and regulatory requirements.
• Identify areas for improvement in the QA processes and implement effective solutions.
• Conduct risk assessments and manage quality-related risks to ensure product safety and efficacy.

Requirements

• BS, in Math, Science, Engineering, or related technical field.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a manager role preferred.
• In-depth knowledge of drug GMP's with training experience required.
• Extensive verbal and written communication skills, and keyboarding skills with knowledge of Word processing and spreadsheet skills are required.
• Strong leadership, communication, and problem-solving skills. Ability to work collaboratively with cross-functional teams.

Benefits

• Paid time off
• 401(k) retirement savings with company match
• Medical, dental, vision, life and disability insurance
• Competitive pay
• Flexible spending account
• Tuition reimbursement
• Training and employee development programs