Senior Director, Quality & Compliance

Role Overview

• Lead and maintain GCP quality assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements.
• Provide ICH/GCP compliance guidance throughout the clinical development life cycle.
• Plan, oversee, and conduct GCP audits including but not limited to qualification and re-qualification of vendors, internal process, site, TMF and other document audits.
• Manage Quality and Compliance functional activities, including implementation and management of the QMS, inclusive of SOPs, Training and CAPAs.
• Work closely with the Quality and Compliance staff and Operational Functions to provide strategic compliance advice and guidance.
• Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non-compliance.
• Review clinical and nonclinical documentation to ensure regulatory compliance, data integrity, and adherence to GCP standards.
• Oversee quality events, deviations, and CAPA processes related to GCP activities.
• Lead and support global health authority inspections.
• Provide GCP guidance and training to cross-functional teams to promote a culture of quality and regulatory compliance.
• Lead and develop Clinical QA staff while supporting continuous improvement of GCP and quality systems.
• Supervisory responsibility of Quality & Compliance employees (where applicable).
• Provide quality support to Sponsors in line with established or new Quality Agreements (where applicable).
• Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g., PMDA, MHRA, etc.).
• Provide ICH/GCP guidance, auditing advice and training to internal and external clients.
• As part of the Management Team, help counsel on and direct quality initiatives to provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally.
• Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project kick-off meetings.
• Review/audit documents intended for submission to the FDA or other regulatory agency or body to assure compliance with regulatory standards.
• Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients.
• Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine.
• Maintains current knowledge of regulations and guidance documents, providing expert analysis to project
• Other duties as assigned.

Requirements

• Requires 10+ years of experience in GCP Quality Assurance within a CRO, biotechnology or pharmaceutical industry.
• Bachelor’s degree in life sciences or a related scientific field (advanced degree preferred).
• Demonstrated experience conducting and leading GCP audits across clinical sites, Internal Process audits, TMF audits and Vendor qualification audits.
• Strong knowledge of FDA, EMA, and ICH regulations, including global GCP guidelines.
• Experience supporting regulatory inspections and inspection readiness activities.
• Strong leadership and communication skills with the ability to work cross-functionally across clinical and nonclinical teams.
• Ability to interpret regulatory requirements and translate them into effective quality systems, procedures, and risk-based approaches.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation
• Discretionary annual bonus