Senior Manager, Quality (Lynchburg, VA)

The Quality Sr. Manager will manage the Quality Control (QC), Analytical Development (AD), and Quality Assurance (QA) Stability groups, ensuring that all OTC monograph, ANDA/NDA and cosmetic products meet the highest standards of quality and compliance with regulatory requirements. This role involves managing Quality processes, supporting regulatory inspections, leading audits, and implementing quality systems to maintain product integrity and safety.

Key Responsibilities

• Team Leadership: Manage and mentor the Quality management team, scientists and analysts within the Quality Control, Analytical Development and QA stability teams, fostering a culture of quality and teamwork. Define team objectives and provide training on regulatory requirements and quality processes.
• Control Management: Oversee the Quality Control (Chemistry and Microbiology) laboratories ensuring that our OTC drugs (including NDA products) and cosmetic products and materials meet defined specifications and quality standards. Maintain the departmental budget.
• Analytical Development Management: Oversee AD efforts involved with new product introduction including analytical method development, validation, and transfer to QC laboratories to ensure the quality and safety of our OTC and Cosmetic products. Maintain the departmental budget.
• Laboratory Investigations: Oversee the timely completion and escalation of laboratory investigations for the QC Chemistry, QC Microbiology, and Analytical Development areas, and Environmental Monitoring program.
• Project Management: Provide an active leadership role in the ongoing Lab Expansion project. Provide oversite of both day-to-day laboratory activities and balanced involvement in ensuring the timely progression of the lab expansion project activities in coordination with project leaders.
• Training & Development: Provide training and guidance to staff on quality standards, regulatory compliance, and best practices in quality assurance.
• Quality System Development: Develop, implement, and maintain quality management systems in collaboration with Quality leaders, including standard operating procedures (SOPs), to ensure compliance with cGMPs.
• Documentation Review: Review and approve technical documents, product specifications, and quality-related documentation to ensure adherence to established standards.
• Risk Management: Identify potential quality issues and work with cross-functional teams to implement risk assessments and mitigation strategies.
• Continuous Improvement: Analyze quality performance metrics and implement initiatives to enhance quality standards and operational efficiency.
  
  

Qualifications

• BS, in Math, Science, Engineering, or related technical field.
• Minimum of 7 years of experience in Quality within the pharmaceutical industry, with at least 2 years in a manager role preferred.
  
  

What We Offer

Here at Fleet, you can have a good job that can grow into a great career.

• The start of a great career working with a diverse group of great people
• The health and safety of every employee... our top priority
• A clean, air-conditioned cGMP environment
• Top notch benefits –paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, Flexible spending account, and tuition reimbursement.
• Stability – a record of strong financial performance and part of a growing $1billion company
• A business supporting the Lynchburg community for over 150 years.
  
  

No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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