Associate Director, QA Manufacturing Technical Services

Responsibilities

• Lead and oversee the deviation management process, ensuring thorough investigation, documentation, and resolution in accordance with regulatory requirements.
• Provide technical expertise in root cause analysis for deviations, including OOS/OOTs, and oversee the implementation of effective CAPAs.
• Partner with cross-functional teams including Manufacturing, QC, MSAT, and Regulatory Affairs to ensure alignment with patient safety and product quality.
• Provide real-time, on-the-floor Quality support for manufacturing operations, including troubleshooting and batch execution support.
• Establish and maintain deviation tracking systems and present regular metric reports to senior leadership.
• Drive continuous improvement and quality remediation activities using methodologies such as LEAN or Six Sigma.
• Support internal and external audits by ensuring all deviation records are maintained in a compliant, audit-ready manner.

Requirements

• Bachelor's degree in biotechnology, life sciences, or a related field.
• 8+ years of relevant industry experience in manufacturing, QA, or QC within a biotechnology or regulated pharmaceutical environment.
• In-depth knowledge of GXP life cycle, specifically within Cell & Gene therapy or Biologics.
• Expertise in Root Cause Analysis (RCA), CAPA, and change control processes.
• Substantial experience using electronic document management systems such as Trackwise or Veeva.
• Strong understanding of aseptic manufacturing operations and regulatory standards (FDA, EMA, cGMP).

Preferred Qualifications

• Master's degree in a relevant scientific field.
• Experience with Operational Excellence methodologies such as LEAN, DMAIC, or Six Sigma.
• Proven track record of managing complex projects and leading cross-functional teams.

Benefits

• Medical, dental, and vision insurance.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• 401(k) with company matching.
• Educational assistance and student loan repayment programs.
• Commuting subsidies and annual bonus/equity award eligibility.

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to advancing clinical and research programs in areas such as cystic fibrosis, sickle cell disease, and other life-shortening genetic diseases.