Director, Clinical Quality Assurance

Job Title: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: 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.
• Quality Systems Support for Clinical Development: 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.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: 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.
• Inspection Readiness and Health Authority Support: 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.
• Risk-Based Quality Management: 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.
• Inspection-Ready Documentation and TMF Support: 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.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

 Job Location:

• Remote; Waltham, MA candidates preferred

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.