Director, Clinical Quality Assurance

Key Responsibilities

• Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures.
• Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle.
• Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation.
• Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development.
• Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues.
• Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement.
• Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs.
• Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs.
• Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed.
• Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness.
• Travel to clinical sites, vendors, and investigator meetings as needed.
• Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination.
• Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities.
• Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.
• Embed risk-based quality management principles into study oversight and clinical quality processes.
• Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals.
• Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.
• Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records.
• Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.
• 10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
• Strong knowledge of GCP and applicable global clinical regulatory requirements.
• Experience supporting quality oversight for Phase 1–3 clinical trials.
• Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
• Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
• Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
• Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
• Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.
• Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).

Preferred Qualifications

• Experience as an early Clinical QA hire in a growing biotech company.
• Experience supporting biologics development programs.
• Familiarity with eQMS tools and clinical systems relevant to quality oversight.
• Experience with risk-based quality management and quality metrics.

Job Location

Remote; Waltham, MA candidates preferred

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.