Director of Quality Assurance, CROInClin is seeking an experienced, forward-thinking Director of Quality Assurance to lead our Quality function and help shape the future of Quality and Compliance across our clinical development programs.
The right candidate must have these requirements to be considered:- Experience in a CRO environment supporting multiple clients, clinical programs, and therapeutic areas.
- Certified Quality Auditor (CQA), Regulatory Affairs Professionals Society (RAPS), Regulatory Affairs Professionals Society Quality Assurance (RQAP), or other relevant Quality or regulatory certification.
- Experience supporting business development, client presentations, and Quality-related bid-defense activities.
This is a full-time, exempt, fully remote position offering competitive compensation and a comprehensive benefits package. At InClin, we value collaboration, flexibility, and employee well-being. Enjoy the freedom of working remotely, supported by the resources and infrastructure you need to succeed, along with generous benefits including medical, dental, and vision insurance, 401(k), paid time off (PTO), company holidays, and more. Join a collaborative team where your expertise makes a difference!
Reporting directly to the Senior Vice President of Quality, this is an opportunity to combine strategic leadership with hands-on Quality expertise in a collaborative, client-focused CRO environment.
In this highly visible role, you will lead and develop the internal Quality team, strengthen InClin's Quality Management System (QMS), and partner with cross-functional teams and clients to advance clinical quality, manage risk, and drive continuous improvement. You will play a key role in ensuring regulatory readiness, maintaining global compliance, and delivering practical, risk-based Quality solutions that support successful clinical development.
We are looking for a confident, collaborative Quality leader who can translate complex regulatory requirements into effective practices, build trusted partnerships, and foster a culture where Quality, integrity, and scientific excellence are integral to everything we do.
Key Responsibilities- Lead and Inspire: Lead, mentor, and develop the internal Quality team while establishing priorities, performance goals, and strategies aligned with InClin's business objectives.
- Drive Quality Excellence: Oversee and continuously improve InClin's QMS, ensuring processes and practices meet applicable global regulatory requirements and industry standards.
- Champion Risk-Based Quality: Proactively identify and assess compliance risks, advise stakeholders, and develop practical mitigation strategies that protect clinical trial quality and data integrity.
- Oversee Audits and CAPAs: Lead risk-based audit programs covering internal functions, clinical sites, CROs, laboratories, vendors, and service providers. Ensure findings are addressed effectively and corrective and preventive actions are sustained.
- Lead Inspection Readiness: Direct inspection-readiness initiatives and coordinate preparation for regulatory inspections and client audits, helping ensure InClin is prepared to demonstrate compliance and operational excellence.
- Shape Regulatory Strategy: Monitor evolving global regulations and guidance, assess their impact, and guide implementation across the organization.
- Strengthen Systems and Compliance: Provide Quality oversight of computerized systems and applicable requirements for electronic records, signatures, system validation, data integrity, eCRF, eTMF, and eCTD processes.
- Develop Quality Expertise: Deliver relevant Quality and regulatory training to InClin personnel, clients, and external partners across applicable GCP, GVP, GCLP, and other GxP areas.
- Influence Through Insights: Establish meaningful Quality metrics, identify emerging trends, and present actionable recommendations and Quality performance updates to the SVP of Quality and senior leadership.
- Build Client Partnerships: Serve as a trusted Quality resource for clients, contribute to client presentations and bid-defense meetings, and support business development initiatives.
- Foster Continuous Improvement: Build strong cross-functional relationships and champion a proactive, collaborative Quality culture focused on compliance, efficiency, and continuous improvement.
Education and Experience- Bachelor's degree in biological sciences or a related scientific discipline required
- 10 to 15 years of relevant experience in clinical research, Quality Assurance, clinical development, or the biopharmaceutical industry.
- 5 to 10 years of progressive experience in global Clinical Development Quality and Compliance.
- Extensive experience supporting all phases of clinical trials.
- Demonstrated experience leading Quality teams, managing QMS processes, and overseeing risk-based audits, CAPAs, and inspection readiness.
- Proven experience supporting successful regulatory inspections, including FDA and EMA inspections.
Knowledge, Skills, and Abilities- Strong knowledge of ICH GCP, FDA regulations, GVP, and applicable global regulatory requirements; familiarity with GCLP and other GxP standards.
- Working knowledge of 21 CFR Part 11, computerized systems compliance, electronic records and signatures, and clinical systems requirements.
- Excellent leadership, mentoring, analytical, problem-solving, and decision-making skills.
- Strong technical writing, communication, presentation, and interpersonal skills.
- Ability to communicate complex regulatory risks and provide practical, risk-based recommendations.
- Proven ability to lead cross-functional teams, build effective working relationships, and manage multiple priorities in a fast-paced CRO environment.
- Demonstrated commitment to integrity, ethical conduct, data integrity, and scientific quality.
- Ability to travel domestically and internationally as required; anticipated travel up to 25%.
Compensation Range: $175,000 - $236,000 annually (depending on experience)At InClin, Quality Assurance is more than a compliance function-it is a vital part of how we support our clients and advance clinical development. As Director of Quality Assurance, you will have the opportunity to influence Quality strategy, develop talented professionals, strengthen client partnerships, and make a meaningful contribution to the integrity and success of clinical research.
