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.

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCP Quality AssuranceGCP auditsQMS implementationSOP managementCAPA processesregulatory compliancedata integrityclinical documentation reviewquality event oversightregulatory document auditing

Soft Skills

leadershipcommunicationcross-functional collaborationstrategic compliance advicetrainingmentoringproblem-solvinganalytical skillsteam developmentcontinuous improvement