Associate Director, QA Ops

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 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 a strategic and experienced Associate Director, QA Operations, to provide quality oversight of cGMP manufacturing activities within our cell therapy operations. This role is a key member of the site Quality Leadership Team, responsible for ensuring compliance across sterile manufacturing environments while driving continuous improvement and fostering a strong culture of quality. The ideal candidate brings deep technical expertise, leadership experience, and the ability to partner cross-functionally to support operational excellence and regulatory compliance.

• Provide end-to-end quality oversight of cGMP manufacturing operations, including sterile processing across Grades A/B/C/D environments

• Ensure alignment with global quality standards, regulatory requirements, and customer Quality Agreements across all QA activities

• Partner with cross-functional teams (Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain) to resolve complex quality issues, including deviations, CAPA, and change controls

• Lead and participate in key quality governance forums, including Change Control, Deviations Review Board, CAPA Board, and Site Quality Council

• Manage, develop, and mentor QA staff, including resource planning, performance management, and talent development

• Drive continuous improvement initiatives to enhance quality systems, operational efficiency, and overall GMP compliance

• Support regulatory inspections and customer audits, ensuring audit readiness and effective response to findings

What we are looking for:

• Bachelor’s degree in science, Engineering, or a related field; advanced degree (MS/PhD) preferred

• 8–12 years of experience in quality assurance within a biotechnology, pharmaceutical, or regulated manufacturing environment

• Demonstrated leadership experience managing and developing teams within a GMP environment

• Strong knowledge of cGMP regulations, sterile manufacturing, and cell therapy or biologics operations

• Proven experience leading or supporting deviations, CAPA, change control, and quality investigations

• Experience with enterprise quality systems (e.g., TrackWise, LIMS, ELN, SAP or similar platforms)

• Strong analytical and decision-making skills, with the ability to interpret data and drive risk-based quality decisions

• Excellent communication and leadership skills, with the ability to influence stakeholders and operate effectively in a cross-functional, matrixed environment