[Hiring] Senior Director, Quality & Compliance @Precision Medicine Group

Role Description

The Senior Director, Quality & Compliance provides strategic and operational leadership for clinical quality assurance to ensure studies are planned, conducted, documented, and reported in compliance with applicable global regulations (e.g., ICH E6 GCP), sponsor requirements, and Precision procedures. This role leads the design, implementation, and continuous improvement of GCP-focused quality systems and oversight activities, including risk-based audit programs (sites, vendors, internal process, and TMF), issue management (deviations, quality events, and CAPA), inspection readiness, and support of health authority and Sponsor audits/inspections. Partnering cross-functionally with Operations and other stakeholders, the Senior Director proactively identifies and mitigates quality and compliance risks, drives a culture of quality and data integrity, and develops and mentors QA professionals while serving as a trusted advisor to internal teams and external clients.

Qualifications

• 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.

Requirements

• Availability to travel up to 25% domestically and/or internationally.
• Supervisory/management experience leading quality personnel.

Benefits

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