Establishment, implementation, and continuous improvement of the company’s Quality Management System (QMS) to support its clinical-stage biopharmaceutical development programs while ensuring compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH) and Gx P standards (GMP, GDP, GCP, GLP).
Cross-functional collaboration to embed a proactive quality culture, align Gx P activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness.
Duties and responsibilities :
QMS Development & Implementation
- 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 Gx P 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 Gx P 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
• Strong command of phase-appropriate Gx P and ICH Q-series guidelines
• Skilled in e QMS 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 c GMP, GLP, and regulatory compliance frameworks
- Experience in managing global quality audits, CAPA, and risk assessments.
This position operates in an office setting, in person.
Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Cross-functional collaboration to embed a proactive quality culture, align Gx P activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness.
Duties and responsibilities :
QMS Development & Implementation
- 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 Gx P 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 Gx P 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
• Strong command of phase-appropriate Gx P and ICH Q-series guidelines
• Skilled in e QMS 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 c GMP, GLP, and regulatory compliance frameworks
- Experience in managing global quality audits, CAPA, and risk assessments.
This position operates in an office setting, in person.
Job may additionally require incumbent to be available outside of these hours to handle priority business needs.