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.

What you will do:

We are seeking an experienced Quality Assurance Manager, Operations to lead a team supporting GMP compliance and quality oversight across site operations. This role is responsible for ensuring quality objectives are achieved, supporting cross-functional teams, and promoting a strong culture of quality and continuous improvement. The ideal candidate will bring leadership experience within a regulated manufacturing environment and the ability to effectively manage priorities, people, and processes.

• 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

What we are looking for:

• 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