Associate Director – Technical Quality

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide strategic and operational guidance over external partners for designated programs.

• Ensure that outsourced manufacturing, analytical testing, packaging, labeling, and distribution adhere to global cGMP, GDP, and regulatory standards.

• Negotiate, execute, and supervise Quality Agreements.

• Conduct supplier audits and manage qualifications.

• Provide quality oversight for technology transfer, CDMO GMP manufacturing, CTL testing, and clinical trial product packaging, labeling, and distribution.

• Review CDMO manufacturing and testing documentation, including batch records, change controls, and deviations.

• Oversee and approve lot release and disposition for products and starting materials.

• Manage the execution of packaging and labeling.

• Ensure compliance with cold-chain and distribution standards, including temperature excursions.

• Implement and lead QP batch certification for EU/UK distribution.

• Establish and monitor Key Quality Indicators for outsourced operations.

• Serve as QA Lead during joint company/supplier meetings and contribute to governance charters.

• Monitor supplier performance and suggest improvement actions.

• Lead or assist with regulatory inspections and manage responses to observations.

• Act as QA Lead on cross-functional program teams and assist in regulatory submission packages.

• Identify risks and assess deficiencies, collaborating across functions on remediation efforts.

• Oversee quality system documents and records, including SOPs, change controls, deviations, and CAPAs.

• Drive continuous improvement of the GMP quality management system.

• Foster a company-wide culture of quality and collaborate on the quality manual and policy.

• Report to the Senior Director of Technical Quality.

⛳️ Requirements

• Bachelor’s degree in a science-related discipline; relevant experience may be considered in lieu of a degree.

• At least 10 years of hands-on technical Quality Assurance experience in biotech for Associate Director, or 15 years for Director.

• Comprehensive understanding of GMP quality for raw materials, drug substance, drug product, analytical testing, labeling, packaging, and distribution.

• Minimum of 3 years in a leadership position directly overseeing outsourced activities, including CDMOs and CTLs.

• Experience in establishing supplier oversight programs is preferred.

• Familiarity with biologics manufacturing processes and analytics during clinical and commercial phases.

• Previous experience in manufacturing/QC operations is strongly preferred.

• Prior experience in AAV gene therapy is highly preferred.

• Knowledge of process and analytical technology transfer, including comparability and bridging requirements.

• Experience in bringing a product to commercialization.

• Direct experience with regulatory agency inspections is a must.

• Capability to work autonomously and make decisions with minimal oversight.

• Strong skills in collaboration, team-building, and organization.

• Willingness to travel less than 10% for supplier site visits and company meetings.

🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Competitive health and dental programs with flexible options.

• Flexible Spending Account (FSA) and Health Savings Account (HSA) programs.

• 401(k) plan with competitive company matching contributions.

• Employee Stock Purchase Plan.

• Mobile phone subsidy for eligible employees.

• Tuition reimbursement.

• Vision coverage.

• Life insurance.

• Optional pet insurance.

• Employee discount program on travel, entertainment, and services.

• Employee assistance programs.

• Daily subsidized lunch delivery (onsite @ Hood Park).

• Free onsite full-service gym (onsite @ Hood Park).

• Employee parking (onsite @ Hood Park).

• 12 observed holidays and a winter shutdown.

• 15-day PTO policy with an 80-hour rollover year over year.

• 40-hour sick leave policy.

• 8-hour floating holiday.