Manager Quality Assurance (Lynchburg, VA)

Prestige Brands Holdings - Lynchburg, VA

Full-time - Manager

Lynchburg, VA

Merchant Wholesalers, Nondurable Goods

About the position

The QA 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.
• Ensure regulatory and corporate compliance.
• Ensure department goals are aligned with business imperatives.
• Ensure performance goals are met.
• Establish and ensure achievement of all unit Key Performance Indicators (KPIs).
• Ensure compliance with corporate standards (e.g., financial, code of business conduct) and adherence to company policies.
• Support business processes and requirements.
• Provide leadership, direction and support to QA functions.
• Promote open and honest communication.
• Foster 'team building.'
• Foster a culture focused on problem solving and process improvement.
• Ensure decision making at proper levels.
• Ensure clear roles and responsibilities.
• Engage workforce.
• Maintain positive employee morale.
• Determine resource planning and deployment strategy.
• Ensure systems and processes are in place to maintain smooth operations during employee absences and staffing changes.
• Foster culture that values diversity and promotes respect, inclusion, cooperation, and responsibility.
• Lead by example.

Requirements

• BS, in Math, Science, Engineering, or related technical field.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a supervisory role.
• 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.
• Interacts extensively with internal cross functional teams, suppliers and contractors, consultants, the FDA and other regulatory agencies, and with our corporate office.
• Interacts with the QA department, Operations, Engineering, Supply Chain, and R&D department, Sales department, Regulatory and Marketing during new product development.

Benefits

• Paid time off
• 401(k) retirement savings with company match
• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Flexible spending account
• Tuition reimbursement
• Training and employee development programs