Quality Management System Manager

Job

Reports

• Develop, implement, and maintain a phase-appropriate Quality Management System aligned with FDA, EMA, and ICH requirements.
• Establish, review, and update Quality System documentation (SOPs, policies, templates) to support GxP operations (GMP, GDP, GCP, GLP).
• Serve as system owner for the electronic QMS (e.g., Veeva,) and ensure effective document control.
• Drive QMS maturity and scalability as programs advance from early clinical to IND, IMPD, and BLA stages.
• Monitor QMS performance through defined KPIs and implement continuous improvement initiatives

Compliance, Audits & Quality Oversight

• Ensure organizational compliance with internal quality standards and global regulatory expectations.
• Lead internal audit programs and coordinate external audits and inspections (regulatory, customer, or vendor).
• Manage audit findings and CAPAs to ensure timely closure and sustained compliance.
• Partner with cross-functional teams (Clinical, Manufacturing, Regulatory) to ensure consistent application of quality principles.
• Support vendor qualification and ongoing oversight of CMOs, CROs, and testing laboratories.

Deviation, CAPA, and Change Control

• Oversee deviation, investigation, and CAPA systems to ensure effective root cause analysis and preventive action.
• Manage change control processes for systems, procedures, and documentation, including risk and impact assessments per ICH Q9.
• Foster a culture of accountability and proactive issue prevention across functions.

Document & Training Management

• Administer document management and training systems to maintain inspection readiness.
• Ensure training programs align with current procedures, regulatory requirements, and company quality objectives.
• Track and report compliance metrics, including training completion and document revision cycles.

Inspection Readiness and Continuous Improvement

• Support preparation for regulatory inspections and sponsor audits, ensuring organizational readiness
• Conduct periodic management reviews of QMS performance, providing metrics and compliance trend analyses to senior leadership
• Champion continuous improvement and quality culture initiatives to enhance operational excellence

Qualifications and Experience

• Master's or doctorate degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.
• 8 to 12 years of experience in Quality Assurance or Quality Systems within the biotechnology or biopharmaceutical industry
• Proven track record in developing, implementing, and managing QMS within GMP-regulated environments
• Familiarity with GxP compliance requirements across clinical development and manufacturing
• Experience supporting regulatory inspections (FDA, EMA) and interacting with CMOs, CROs, and regulatory authorities
• Hands-on experience with electronic QMS platforms (e.g., Veeva,) is mandatory
• Prior experience managing an electronic QMS platform desirable
• Prior work experience in clinical-stage or early commercial-stage biotech preferred
• A Strong command of phase-appropriate GxP and ICH Q-series guidelines
• Skilled in eQMS administration, quality documentation, and compliance monitoring
• Proficient in Veeva Vault and Regulatory Information Management Systems (RIMS) to streamline document management and regulatory compliance processes
• Effective communicator with cross-functional teams across R&D, Clinical, Manufacturing, and Regulatory functions
• Excellent analytical thinking, problem-solving, and organizational skills with the ability to manage multiple Priorities
• Deep understanding of bio-therapeutics manufacturing, gene/cell therapy operations
• Strong knowledge of cGMP, GLP, and regulatory compliance frameworks
• Experience in managing global quality audits, CAPA, and risk assessments.

Working Conditions:

Direct Reports :