Quality Assurance Manager, Operations

What You Will Get

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

What You Will Do

• Lead and manage a team of QA Compliance Specialists and QA Project Managers, ensuring timely and effective delivery of quality objectives.
• Provide guidance and act as a point of escalation for quality-related issues impacting internal and external stakeholders.
• Ensure alignment with regulatory requirements, customer Quality Agreements, and internal SOPs across all QA activities.
• Partner cross-functionally with Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain to resolve complex quality issues.
• Support and participate in key quality forums, including Change Control, Deviations Review Board, CAPA Board, and Site Quality Council.
• Oversee and track quality metrics, including deviation trending and performance indicators, to support continuous improvement.
• Drive continuous improvement initiatives to enhance quality systems, processes, and overall site compliance.
• Perform and support lot release and disposition activities in accordance with GMP standards.

About the Role

The typical work schedule is Monday through Friday, 8:00 AM–4:30 PM EST.

Qualifications

• 5–10 years of experience in quality assurance within a biotechnology, pharmaceutical, or regulated manufacturing environment.
• Proven experience managing and developing teams, including coaching, performance management, and talent development.
• Strong knowledge of GMP regulations, quality systems, and compliance requirements.
• Experience supporting or leading investigations, deviations, CAPA, and change control processes.
• Able to effectively collaborate with cross-functional teams and influence decision-making in a matrixed environment.
• Strong organizational and analytical skills, with the ability to manage multiple priorities and meet deadlines.
• Excellent communication skills, with the ability to engage effectively across all levels of the organization.
• Experience with systems such as TrackWise, SAP, Syncade, and Microsoft Office tools is preferred.

Benefits

Below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).