GCP/GVP Quality Senior Manager/Associate Director

Location: Waltham (hybrid)

Department: Quality

Reports to: Sr. Director, Quality Assurance

Role Summary

The GCP Quality role provides quality oversight and compliance leadership for multiple multi-national clinical studies. This position partners with Clinical Operations, Data Management, Pharmacovigilance, Regulatory, and multiple external vendors to ensure trials are conducted in accordance with all applicable external requirements and internal procedures. This role will drive a risk-based approach spanning planning, execution, and close-out of all quality activities during the clinical trial phases. The ideal candidate will be hands-on, pragmatic, and capable of influencing cross-functional teams in a fast-paced, lean, globally distributed environment.

Key Responsibilities

Study Quality Oversight

• Serve as Clinical Quality Lead for all Sironax trials, supporting end-to-end oversight from start-up through close-out.
• Partner with Clinical Operations to embed risk-based quality into key study deliverables (e.g., Quality Oversight Plans, Monitoring Plans, Vendor Oversight Plans).
• Provide QA guidance on protocol implementation impacts (e.g., critical-to-quality factors, data integrity risks, endpoint sensitivity, blinding risks).
• Review and/or approve key study documents per SOP (e.g., monitoring plans, vendor plans, risk assessments, oversight plans, escalation pathways).

Vendor Qualification & Oversight

• Support selection, qualification, and ongoing oversight of GCP vendors.
• Review vendor quality documentation (SOPs, validation packages, training approach, deviation/CAPA processes).
• Ensure robust quality agreements (as applicable) define responsibilities for compliance, issue management, and inspection support.
• Track vendor performance and quality metrics; lead or support governance and escalation for quality concerns.

Audits & Compliance Assessment

• Plan and conduct (or oversee) GCP audits, such as vendor audits, system audits, TMF/eTMF audits, Investigator site audits, etc
• Draft clear audit reports, negotiate findings, and ensure timely, effective CAPA
• Drive cross-functional alignment on corrective and preventive actions for issues identified (e.g., through audits, risk assessments, etc).

TMF/eTMF Quality Oversight

• Provide oversight of TMF completeness, quality, and inspection readiness throughout the lifecycle.
• Define/monitor TMF metrics (completeness, timeliness, QC rates, artifact quality).
• Support TMF remediation activities and ensure archival readiness at study close-out.
• Partner with Clinical Operations and TMF teams to ensure filing model clarity (working vs authoritative repository; finalized documents in eTMF).

Computerized Systems & Data Integrity Oversight (GCP Impacting Systems)

• Support oversight of validated systems used in clinical trials (e.g., EDC, eTMF, IRT/IWRS, safety systems, eCOA).
• Review vendor validation packages and sponsor validation approach where applicable.
• Provide guidance on Part 11 expectations (audit trails, access controls, e-signatures, record retention) in collaboration with IT/CSV and Quality Systems.

Inspection Readiness & Regulatory Interactions

• Maintain ongoing inspection readiness for assigned trials (inspection-ready TMF, traceability of oversight, CAPA health).
• Support responses to health authority inspections (FDA/EMA/MHRA/other) and partner/vendor inspections.
• Lead or contribute to inspection preparation activities (storyboards, document request logs, SMOEs, interview preparation).

Quality System Development & Continuous Improvement

• Contribute to the development and maintenance of clinical quality SOPs, work instructions, and templates.
• Help implement scalable quality processes suitable for a growing clinical pipeline (phase-appropriate oversight).
• Identify and implement continuous improvement initiatives across clinical quality processes, vendor governance, and training.

Training & Culture

• Deliver or coordinate GCP and quality training for cross-functional teams and vendors (as applicable).
• Promote a culture of quality, transparency, and continuous improvement.

Qualifications

• Bachelor’s or advanced degree in Life Sciences, Engineering, or a related discipline.
• Minimum 10 years in quality function within pharmaceutical or biotech, with at least 5 years leading GCP audits.
• Experienced in leading QCP for global trials.
• Expert level working knowledge of ICH E6(R3)
• Experience in 'front-room' during FDA and other agency audits desired.
• Strong knowledge of FDA, EMA, and ICH guidelines.
• Knowledge of computerized system validation concepts in a GCP environment.
• Experience in multiple therapeutic spaces is a plus.
• Ability to work independently and influence cross-functional teams.
• Excellent problem-solving and risk-based decision making skills in a fast-paced, global environment.
• Ability to work with geographically and culturally diverse teams.

Equal Opportunity Employer

Sironax is an equal opportunity employer committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and are dedicated to creating a work environment where everyone feels valued and empowered.