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 GxP standards (GMP, GDP, GCP, GLP).
Cross-functional collaboration to embed a proactive quality culture, align GxP 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 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 readinessConduct periodic management reviews of QMS performance, providing metrics and compliance trend analyses to senior leadershipChampion continuous improvement and quality culture initiatives to enhance operational excellenceQualifications and Experience
Master’s or doctorate degree in Life Sciences, Pharmacy, Biotechnology, or related discipline8 to 12 years of experience in Quality Assurance or Quality Systems within the biotechnology or biopharmaceutical industryProven track record in developing, implementing, and managing QMS within GMP-regulated environmentsFamiliarity with GxP compliance requirements across clinical development and manufacturingExperience supporting regulatory inspections (FDA, EMA) and interacting with CMOs, CROs, and regulatory authoritiesHands-on experience with electronic QMS platforms (e.G., Veeva,) is mandatoryPrior experience managing an electronic QMS platform desirablePrior work experience in clinical-stage or early commercial-stage biotech preferredStrong command of phase-appropriate GxP and ICH Q-series guidelinesSkilled in eQMS administration, quality documentation, and compliance monitoringProficient in Veeva Vault and Regulatory Information Management Systems (RIMS) to streamline document management and regulatory compliance processesEffective communicator with cross-functional teams across R&D, Clinical, Manufacturing, and Regulatory functionsExcellent analytical thinking, problem-solving, and organizational skills with the ability to manage multiple PrioritiesDeep understanding of bio-therapeutics manufacturing, gene / cell therapy operationsStrong knowledge of cGMP, GLP, and regulatory compliance frameworksExperience 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.
