Sr. Consultant, Quality and Compliance

Responsibilities

• Establish and execute sponsor oversight programs for clinical trials, including CRO qualification and risk-based quality oversight
• Serve as the independent quality liaison between client sponsors and various clinical vendors
• Author and approve quality agreements, clinical vendor SOPs, and oversight plans
• Plan, conduct, and report GCP audits, including investigator sites, CROs, and TMF audits
• Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation
• Author audit reports with regulatory citations and track CAPA commitments
• Review clinical trial documents (protocols, ICFs, IBs) for GCP compliance
• Oversee TMF quality, including completeness and ALCOA+ compliance
• Lead investigations into serious GCP issues such as protocol deviations and data integrity concerns
• Provide quality input on regulatory submissions (IND, NDA, BLA)
• Maintain knowledge of evolving GCP regulations and translate changes into client recommendations

Requirements

• Bachelor's degree in life sciences, chemistry, pharmacy, nursing, or related discipline
• Minimum 10 years of progressive experience in GxP-regulated environments
• At least 8 years of dedicated GCP experience in a sponsor, CRO, or consulting setting
• Demonstrated experience leading at least 25 GCP audits independently
• Direct experience supporting at least one FDA BIMO or equivalent regulatory inspection
• Hands-on experience with risk-based quality management (RBQM) programs
• Proficiency with eTMF systems (Veeva Vault Clinical, Phlexglobal) and eCRF/EDC platforms
• Working command of 21 CFR Parts 11, 50, 54, 56, 312, and 812

Preferred Qualifications

• Advanced degree (MS, PharmD, PhD, or MPH)
• Professional certification such as RQAP-GCP, SQA, or ACRP-CP
• Experience auditing decentralized clinical trials (DCTs) or hybrid trials
• Experience in oncology, rare disease, or cell and gene therapy
• Prior experience as an interim or virtual Head of Clinical Quality
• Former regulatory authority experience (FDA, EMA, MHRA)

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.