Associate Director/Director, Technical Quality

Solid Biosciences Inc.; Northern (KY); Hybrid; USD 190,000 - 230,000; Full time

Benefits offered by this job

Health and dental

401(k)

Employee stock purchase plan

Tuition reimbursement

Onsite gym access

Job summary

Solid Biosciences is a precision genetic medicine company focused on gene therapy candidates for rare neuromuscular and cardiac diseases.

The Associate Director/Director, Technical Quality Assurance will provide strategic and operational leadership over external parties to ensure outsourced manufacturing, analytical testing, packaging, labeling, and distribution activities comply with global cGMP, GDP, and regulatory requirements.

Qualifications

• Bachelor’s degree in a science-related field; experience may substitute for degree.
• Minimum of ten years of direct technical Quality Assurance experience in biotech (Associate Director) or fifteen years (Director).
• Strong GMP understanding for starting materials, drug substance/product, analytics, labeling, and distribution.
• At least three years leading outsourced activities (CDMOs/CTLs).
• Experience with Biologics manufacturing processes and analytics at clinical and commercial stages.
• Experience with process and analytical tech transfer and regulatory inspections.

Responsibilities

• Oversee CDMO/CTL oversight, including supplier audits and quality agreements.
• Lead quality oversight of tech transfer, GMP manufacturing, analytical testing, packaging and distribution for trials and commercialization.
• Review batch records, change controls, deviations, and ensure regulatory compliance.
• Approve lot release and disposition for materials and products.
• Lead regulatory submissions support (pre-IND, IND, IMPD, CTA, BLA).
• Establish and track quality KPIs for outsourced activities.
• Lead inspections and responses, and drive continual GMP QA improvement.

Skills

GMP knowledge

QA leadership

CDMO oversight

Regulatory support

AAV gene therapy

Education

Bachelor's degree in science

Tools

GxP QA systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Associate Director/Director, Technical Quality

.25 Charlestown-HQ, Charlestown, MA, US

8 days ago Requisition ID: 1153

Salary Range: $190,000.00 To $230,000.00 Annually

Associate Director/Director, Technical Quality – Solid Biosciences

Charlestown, MA or Remote (US)

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.

We are seeking an Associate Director/Director of Technical Quality Assurance to provide strategic and operational leadership over external parties for the assigned program(s) to ensure that all outsourced manufacturing, analytical testing, packaging, labeling, and distribution activities comply with global cGMP, GDP, and regulatory requirements.

This role will report to the Senior Director, Technical Quality and is flexible to be fully remote within the United States or based out of Solid’s Corporate Headquarters in Charlestown, MA.

Key Position Responsibilities

CDMO/CTL Oversight

• Negotiate, execute, and provide oversight of relevant Quality Agreements to ensure compliance.
• Lead Supplier Audits and Qualifications.
• Provide Quality oversight to processes including, but not limited to, technology transfer of processes and analytics, CDMO GMP manufacture, CTL testing, and package/label/distribution of high-quality products for clinical trials building towards commercial.
• Review CDMO manufacturing and testing documentation (batch records, change controls, deviations, etc.) to assess completeness, adequacy, as well as compliance with procedures and applicable regulatory requirements.
• Oversee/approve lot release and disposition for products and starting materials.
• Packaging and labeling oversight ensuring batch records and execution meets requirements.
• Cold chain and distribution compliance including temperature excursion management.
• Implement and lead QP batch certification for EU/UK distribution.

Quality Systems & Compliance

• Establish and track Key Quality Indicators for all outsourced activities.
• Act as QA Lead at joint Solid/Supplier periodic meetings and provide input into governance or other charters.
• Monitor performance in collaboration with functional colleagues and provide input into actions required for improvement.
• Act as an inspection lead and/or liaison for regulatory inspections specific to the program and manage responses to observations.
• Act as QA Lead on cross functional program teams, providing input for regulatory submission packages (pre-IND, IND, IMPD, CTA, BLA, etc.) and other documents as requested.
• Identify risk and evaluate deficiencies, collaborating cross-functionally to remediate risk to an acceptable level.
• Oversee quality and effectiveness of quality system documents and records, i.e., SOPs, change controls/notifications, deviations and CAPAs.
• Lead continuous improvement of the GMP quality management system in collaboration with functional leaders.
• Promote a company-wide culture of quality and collaborate with the quality team on development and implementation of a quality manual and quality policy that supports.

Experience Requirements

• Bachelor’s degree in a science-related field (experience may substitute for degree).
• Minimum of ten years (Associate Director) or fifteen (Director) of direct technical Quality Assurance experience in the biotech industry.
• Strong understanding of GMP Quality for starting and critical raw materials, drug substance, drug product, analytical testing, and label/packaging, and distribution.
• Minimum of three years in a leadership role directly managing outsourced activities (CDMOs/CTLs). Preference for establishment of supplier oversight programs.
• Experience and understanding of Biologics manufacturing processes and analytics, at clinical and commercial stage.
• Strong preference for candidates with previous manufacturing/QC operations experience.
• Strong preference for candidates with previous experience in AAV gene therapy experience.
• Experience with process and analytical tech transfer from one site to another including comparability and bridging requirements.
• Experience bringing a product to commercialization.
• Regulatory agency inspection direct experience is required.

Key Position Attributes

• Ability and desire to work independently and make decisions with minimal supervision in a fast-paced environment.
• Strong collaboration, team-building, and organizational skills.
• Anticipate <10% travel for on-site visits to external suppliers and company meetings

Compensation

The base compensation range for this role is: $190,000.00 – 230,000.00

Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

• Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
• 401(k) program participation 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 shut down
• 15-day PTO Policy and a 80-hour rollover YoY