Senior Director, Quality & Compliance

Position Summary:

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.

Key Responsibilities: 

• 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.

Qualifications:

Minimum Required:

• 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.

Other Required:

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

Preferred:

• Graduate, postgraduate degree, ideally in a scientific or healthcare discipline
• CRO, Pharmaceutical and/or Medical Device experience
• Experience hosting client/Health Authority inspections

Skills:

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills

Competencies:

• Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs.
• Resolves project related problems and prioritize workload to meet deadlines with little support from management.
• Exhibits high self-motivation and can work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet timelines and project goals.
• Focuses on continuous improvement, including the ability to make proactive. assessments on how to make processes more efficient and people more effective.
• Ability to review and evaluate clinical data.
• Proven ability to communicate with senior management, external thought leaders and operational staff.
• Advanced proficiency in Microsoft Word, Excel, and PowerPoint, Teams.
• Understands financial management to review proposals and budgets.
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and keen attention to detail.
• Ability to work with cross functional groups and management under challenging situations.
• Ability to prioritize work and handle multiple and/or competing assignments.
• Excellent verbal and written communications skills.

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