Associate Director/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, finalize, and oversee Quality Agreements.

• Conduct supplier audits and qualifications.

• Offer quality oversight for technology transfers, 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.

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

• Ensure compliance in packaging and labeling.

• Manage compliance for cold-chain and distribution, including temperature excursions.

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

• Establish and monitor Key Quality Indicators for outsourced activities.

• Serve as the QA Lead at joint Solid/Supplier meetings and contribute to governance charters.

• Track supplier performance and recommend improvement actions.

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

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

• Identify risks, assess deficiencies, and work collaboratively across functions on remediation.

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

• Drive continuous improvement of the GMP quality management system.

• Collaborate on the development and implementation of a quality manual and quality policy.

⛳️ Requirements

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

• A minimum of ten years of direct technical Quality Assurance experience in the biotech sector for Associate Director; fifteen years for Director.

• Strong comprehension of GMP Quality concerning starting and critical raw materials, drug substances, drug products, analytical testing, labeling, packaging, and distribution.

• At least three years in a leadership role directly managing outsourced activities, including CDMOs/CTLs.

• Preference given to candidates with experience establishing supplier oversight programs.

• Familiarity with biologics manufacturing processes and analytics at clinical and commercial stages is essential.

• Strong preference for prior experience in manufacturing/QC operations.

• Strong preference for previous experience in AAV gene therapy.

• Experience with process and analytical technology transfer, including comparability and bridging requirements.

• Proven experience in bringing a product to commercialization.

• Direct experience with regulatory agency inspections is required.

• Ability and willingness to work independently and make decisions with minimal supervision.

• Excellent collaboration, team-building, and organizational skills.

• Willingness to travel less than 10% for onsite supplier 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 plan offerings, including FSA and HSA options.

• Participation in a 401(k) program with competitive company-matched contributions.

• Eligibility to participate in Solid’s Employee Stock Purchase Plan.

• Mobile phone subsidy for eligible employees.

• Tuition Reimbursement.

• Vision Coverage.

• Life Insurance.

• Voluntary 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 each year.

• 40-hour Sick Policy.

• 8 Hour Floating Holiday.