The Quality Assurance (QA) Manager plays a critical role in overseeing and executing Clinical Quality Assurance activities that uphold and enhance the organization's Quality Management System (QMS). Reporting to Quality Assurance Leadership, this position ensures compliance with ICH GCP, applicable global regulations, and internal quality standards, while fostering a culture of continuous improvement.
The QA Manager leads key quality functions, including audits, quality event management, vendor qualification, training, and risk-based quality planning. This role partners cross-functionally with clinical operations, vendors, sponsors, and leadership to maintain operational excellence and ensure that clinical research activities meet both regulatory and sponsor expectations.
Essential Duties and Responsibilities:Quality Assurance Operations- Manage and monitor clinical QA activities, ensuring compliance with QMS, ICH GCP, and regulatory requirements.
- Execute day-to-day QA operations to support the QMS while meeting business goals and sponsor requirements.
- Foster a quality-focused culture, promoting awareness and driving continuous improvement initiatives across clinical programs.
- Maintain current knowledge of industry best practices, quality trends and evolving regulations, integrating insights into QA decision-making.
Quality Management System (QMS) & Documentation- Develop, author, review, and maintain QMS documentation, including SOPs, Work Instructions, Templates, and Forms.
- Support Quality Management Review (QMR) activities, including data analysis, reporting, and tracking action items to completion.
Quality Events & CAPA Management- Oversee the management of Quality Events and CAPAs, ensuring timely investigation, root cause analysis, effectiveness checks, and closure.
- Review and assess clinical site and vendor Quality Events, ensuring appropriate resolution and compliant documentation.
- Evaluate CAPA plans for adequacy, regulatory alignment, and operational feasibility.
Audits & Inspection Readiness- Lead or support the planning, conduct, and documentation of internal, vendor, and clinical site audits, including detailed reporting and CAPA tracking.
- Lead or support sponsor audits and regulatory inspection readiness, including preparation, hosting, and follow-up activities.
- Author and review audit responses, ensuring timely, accurate, and effective resolution of findings.
Vendor Qualification & Oversight- Lead or support vendor qualification and requalification, including risk-based assessments, audits, and ongoing compliance monitoring.
Risk-Based Quality Management- Apply a risk-based approach to support the planning, prioritization, and execution of quality initiatives.
- Identify, assess, and mitigate quality and compliance risks across clinical studies and operational areas.
Quality Metrics & Continuous Improvement- Analyze quality data and metrics, including audit trends, Quality Events, and CAPA outcomes, to identify patterns and drive process improvements.
- Provide regular reports to senior leadership on quality trends, risks, and mitigation strategies.
Cross-Functional Collaboration- Collaborate with clinical operations, medical, regulatory, and vendor teams to ensure alignment on quality expectations and risk management.
- Provide QA consultation for controlled document development, process optimization, and clinical trial execution.
Business Development & Sponsor Support- Assist with sponsor RFIs, due diligence questionnaires, and quality agreements, ensuring timely and accurate responses.
- Serve as a QA representative in sponsor meetings, fostering strong sponsor relationships and transparent quality communications
- Perform other duties as assigned by management.
Qualifications:Education & Experience- BS/BA/MS in Life Sciences, Pharmacy, Nursing, or a related field, or equivalent combination of education and experience; advanced degree (e.g., MS, MPH) preferred.
- 5-10 years of GCP Quality Assurance experience, preferably in a CRO environment.
Knowledge & Skills- Deep knowledge of ICH GCP, FDA and other global regulatory guidelines.
- Experience in authoring, reviewing, and managing QMS documents and quality records.
- Excellent written, verbal, and presentation skills, with the ability to communicate complex concepts clearly.
- Demonstrated ability to collaborate in cross-functional teams, with a proactive and solution-oriented approach.
- Strong organizational, time management, and prioritization skills; able to manage multiple projects in a fast-paced, matrixed environment.
- Analytical and risk-based thinking, with the ability to interpret quality metrics and drive continuous improvement.
- Effective in influencing, negotiating, and implementing effective quality solutions.
- Meticulous attention to detail with auditing and investigative skills.
- Proficient in Microsoft Office, QMS systems, and electronic Trial Master File (eTMF) platforms.
- Ability to handle sensitive and confidential information with discretion and integrity.
- Ability to travel
Department QA Role Quality Assurance Manager Locations Remote, US Remote status Fully Remote Employment type Full-time
