Senior Consultant, Quality and Compliance

About the role

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here . Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: The Senior Consultant, GCP is an experienced clinical quality professional who independently leads GCP quality and compliance engagements for Syner-G's sponsor clients - primarily virtual and emerging biotechs running Phase 1 through Phase 3 clinical programs. This role functions as the embedded clinical quality voice for client programs: overseeing CROs and clinical vendors, auditing investigator sites and vendor systems, advising on sponsor oversight strategy, and ensuring clinical programs are inspection-ready against FDA, EMA, and ICH GCP expectations. Consistent with the Syner-G Senior Consultant level, the role requires the confidence and judgment to lead client decision-making, defend recommendations against scrutiny, and operate independently across the full clinical development lifecycle. This is an individual-contributor role with significant client-facing accountability; it is not a people-management role. JOB FUNCTIONS (This list is not exhaustive and may be supplemented and changed as necessary.) Independently establish and execute sponsor oversight programs for clinical trials, including CRO qualification, ongoing performance monitoring, and risk-based quality oversight aligned with ICH E6(R3). Serve as the independent quality liaison between client sponsors and CROs, central labs, IRT/RTSM vendors, eCOA/ePRO providers, central imaging vendors, bioanalytical labs, and clinical supply CMOs. Author and approve quality agreements with clinical vendors; review and approve clinical vendor SOPs, validation documentation, and oversight plans before study start. Drive direction of the clinical quality function within client organizations - establish the quality oversight model, define escalation pathways, and align sponsor and vendor responsibilities. Independently plan, conduct, and report GCP audits, including investigator site audits, CRO/vendor system audits, TMF audits, clinical database audits, and for-cause audits. Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation for sponsor clinical sites and key vendors; conduct mock inspections. Author audit reports with defensible findings, regulatory citations, and severity classifications; track CAPA commitments to closure. Build and maintain audit programs (risk-based audit plans, annual schedules, audit metrics) for client sponsors. Review and approve clinical trial documents prior to use - protocols and amendments, ICFs, IB updates, monitoring plans, data management plans, statistical analysis plans, and clinical study reports - for GCP compliance and inspection-readiness. Oversee TMF quality: review TMF completeness, contemporaneousness, and ALCOA+ compliance; advise on eTMF system configuration, indexing, and QC processes. Approve essential documents for clinical trial start-up, including site selection packages, regulatory submissions support documentation, and IRB/EC correspondence. Lead investigations into serious GCP issues including protocol deviations of significance, data integrity concerns, informed consent issues, IP accountability discrepancies, and suspected fraud or misconduct.

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