Quality Assurance Manager, Operations

Lonza • Portsmouth, NH

19h • Onsite

About The Position

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.

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

Nice To Haves

• Experience with systems such as TrackWise, SAP, Syncade, and Microsoft Office tools is preferred

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

Benefits

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed