Quality Assurance Manager, Operations

Responsibilities

• 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
• Perform and support lot release and disposition activities in accordance with GMP standards
• Drive continuous improvement initiatives to enhance quality systems, processes, and overall site compliance

Requirements

• 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
• Ability 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
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Benefits

Additional Information

Quality Assurance Manager, Operations Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM-4:30 PM EST. What you will get: 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). Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

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Company Intel

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