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 (RCA) for deviations, including OOS/OOTs, and oversee the implementation of effective CAPAs.
• Partner with cross-functional teams including Manufacturing, QC, MSAT, and Supply Chain 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 guidance.
• 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 risk assessments and internal/external audits to ensure all records are maintained in a compliant, audit-ready manner.

Requirements

• Bachelor's degree in biotech, life sciences, or a related field.
• Master's degree or a comparable advanced professional background.
• 8+ years of relevant industry experience in biotechnology, manufacturing, or quality assurance within a 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 technical understanding of aseptic manufacturing, cell technology, and analytical assays.

Preferred Qualifications

• Experience with Operational Excellence methodologies such as LEAN, DMAIC, or Six Sigma.
• Proven track record of managing complex projects and leading cross-functional teams.
• Ability to apply risk management principles to operational decision-making.

Benefits

• Competitive salary range with eligibility for annual bonuses and equity awards.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance and student loan repayment programs.
• 401(k) with company matching.
• Commuting subsidies and various wellbeing resources.

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 for life-shortening genetic diseases and is consistently recognized as one of the industry's top places to work.