Senior Quality Assurance Manager
Role Overview
The Senior Quality Assurance Manager is responsible for leading and strengthening the organizations Quality Management System (QMS), ensuring ISO 9001 compliance, and providing clinical trial quality oversight across GxP-regulated activities. This role serves as a key quality partner to cross-functional teams, driving continuous improvement, audit management, inspection readiness, and regulatory compliance.
Key Responsibilities
1. Quality Management System (QMS) & ISO 9001 Compliance
Focus: Oversight, governance and continuous improvement for organizational quality processes.
- Lead the development, implementation, and continuous improvement of the organizations QMS.
- Oversee ISO 9001 certification and surveillance activities, including preparation, coordination, and follow-up.
- Act as the process owner and subject matter expert, guiding stakeholders through the full process lifecycle (documentation, training, effectiveness checks, version control) to remain ISO 9001 compliant.
- Review, revise, and update QMS documents and standards regularly to reflect regulatory changes, operational improvements, and certification requirements.
- Guide and train the team on QMS implementation, best practices, and ISO 9001 certification transitions for new revisions.
- Conduct periodic quality reviews across organizational and functional processes to ensure compliance and operational effectiveness.
- Manage document control processes, ensuring timely updates, proper versioning, and secure archiving of quality documentation.
- Plan and conduct internal audits and facilitate management review meetings.
- Provide strategic quality oversight and advisory support to leadership and operational teams.
2. Quality Systems Administration & Training Management
Focus: Operational support, user enablement, and system-driven quality management.
- Serve as Superuser for the Quality Management System, including Document Control and Training modules.
- Administer system configurations, user access, and governance controls.
- Establish and maintain a structured quality training framework aligned with regulatory and business requirements.
- Provide onboarding and ongoing training on quality processes and systems use.
- Support end users by resolving system queries and enhancing system utilization and compliance.
- Drive continuous enhancement of quality system tools and digital solutions.
3. Clinical Trial Quality Oversight & GxP Auditing
Focus: Ensure robust quality oversight, proactive risk management, and compliance with GxP standards across clinical trials.
- Develop and execute a risk-based Quality Oversight Plan for clinical trials.
- Partner with Clinical Operations and cross-functional teams to ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and applicable regulatory requirements.
- Monitor, analyze and report quality trends, identify potential risks to trial conduct, data integrity and patient safety.
- Recommend and implement process improvements to enhance trial quality, compliance, and documentation practices.
- Plan, conduct, and report GxP audits (GCP and GLP), including audits of service providers, to assess operational compliance, identify risks, and evaluate trial quality and regulatory compliance.
- Prepare comprehensive audit reports and ensure timely follow-up on corrective and preventive actions (CAPAs).
- Lead inspection readiness initiatives, including gap assessments, mock inspections, and documentation reviews, ensuring preparedness for regulatory inspections.
- Develop and maintain inspection readiness roadmaps to ensure sustained regulatory compliance and proactive risk management.
- Provide ongoing quality oversight and advisory support to study teams, ensuring alignment with corporate quality standards and regulatory expectations.
4. Other Quality Activities Supporting R&D Compliance
Focus: Ensure quality, compliance, and oversight in broader research and development activities within the organization.
- Monitor and advise on adherence to internal policies, regulatory requirements, and industry standards for non-clinical research activities regulated under Human Biomedical Research Act (HBRA).
- Support Human Biomedical Research (HBR) Institutional Review Board (IRB) related activities to ensure ethical and compliance in research studies.
- Review and provide quality input on IRB submission documentation.
Contribute to R&D quality improvement initiatives, including SOPs, templates, and training programs that strengthen the R&D compliance culture.
Qualifications & Experience
- Bachelor's Degree in Life Sciences, Operations, or a related discipline.
- Minimum 810 years of experience in Quality Assurance within life sciences, healthcare, or regulated environments.
- Strong experience in SOP management and QMS implementation.
- Solid understanding of ISO 9001 standards and certification processes.
- Demonstrated experience in clinical trial quality oversight and GxP auditing.
- Proven track record in leading internal audits, managing CAPAs, and driving continuous improvement initiatives.
- Strong stakeholder management and communication skills, with the ability to influence at all organizational levels.
- Highly self-motivated, results-oriented, and adaptable to evolving business priorities.
Experience with electronic Quality Management Systems (eQMS) is highly desirable.
