Job Description

We are seeking a highly experienced and dynamic Executive Director (ED) of Clinical Quality Assurance (QA) to lead the Clinical QA department for Fortvita, a growing biotechnology organization with multiple oncology trials at various stages of development. The ED will oversee the design, implementation, and continuous improvement of quality assurance systems to ensure that all clinical trial activities meet the highest standards of regulatory compliance, data integrity, and patient safety. This senior leadership role requires a strategic thinker with a deep understanding of clinical development, oncology, and regulatory frameworks.

The ideal candidate will have a proven track record in clinical quality assurance within the biotech or pharmaceutical industry, preferably with extensive experience managing oncology trials. This is a key role in driving the success of our clinical development programs while ensuring that all clinical trials are conducted in accordance with Good Clinical Practices (GCP), FDA, EMA, and ICH guidelines.

Key Responsibilities:

Leadership & Strategy:

• Lead and develop the Clinical QA team, providing guidance and oversight to ensure the highest standards of quality are maintained across all clinical trial operations.
• Develop and implement the QA strategy for the organization’s portfolio of oncology trials, aligning with company goals, regulatory requirements, and industry best practices.
• Collaborate with senior leadership to ensure the integration of clinical quality assurance into the overall clinical development strategy.

Clinical Trial Oversight:

• Oversee all QA aspects of ongoing oncology clinical trials, ensuring regulatory compliance and adherence to internal policies and procedures.
• Ensure appropriate quality management systems (QMS) are in place to monitor clinical trial activities, including monitoring, auditing, and vendor management.
• Provide direction on trial design and execution to ensure robust quality systems and continuous risk management throughout all phases of clinical development.

Regulatory Compliance & Auditing:

• Lead the internal and external auditing process, ensuring audits are conducted as per the relevant regulations (GCP, FDA, EMA, ICH).
• Manage audit schedules, corrective action plans (CAPAs), and monitor their implementation.
• Prepare and support regulatory inspections and interactions with health authorities (e.g., FDA, EMA) to ensure readiness and compliance during inspections.

Continuous Improvement & Risk Management:

• Establish and maintain systems for the identification, mitigation, and management of clinical trial risks related to quality, safety, and regulatory compliance.
• Develop and implement quality improvement initiatives to enhance the efficiency and effectiveness of clinical trial operations and to reduce quality risks.
• Foster a culture of continuous improvement in clinical QA processes, ensuring lessons learned from trials are incorporated into future study designs and processes.

Collaboration & Communication:

• Collaborate with clinical operations, regulatory affairs, and other cross-functional teams to ensure alignment on quality objectives and seamless execution of clinical trials.
• Serve as the point of contact for all quality-related inquiries and issues, providing expert guidance and leadership across the organization.
• Communicate quality assurance and regulatory compliance expectations clearly to both internal teams and external partners.

Qualifications & Experience:

Education:

• Advanced degree in Life Sciences, Pharmacy, Biotechnology, or a related field (PhD, MD, PharmD, or Master’s level).
• Additional certifications in clinical research (e.g., CCRP, CQA) are preferred.

Experience:

• At least 12-15 years of experience in clinical operations and clinical quality assurance, with a minimum of 8 years in a leadership role within the biotech or pharmaceutical industry.
• Strong background in oncology clinical trials, with demonstrated experience in early-phase and late-phase trial oversight.
• In-depth knowledge of GCP, FDA, EMA, ICH guidelines, and other relevant global regulatory frameworks.
• Experience with regulatory inspections and managing CAPAs.
• Proven track record of leading, mentoring, and building high-performance teams.
• Strong understanding of clinical data management, risk management, and quality systems.

Skills & Abilities:

• Exceptional leadership, communication, and interpersonal skills.
• Strong strategic thinking and problem-solving abilities.
• Ability to manage multiple projects and priorities in a fast-paced, high-growth environment.
• Excellent attention to detail, analytical skills, and a passion for ensuring clinical trials meet the highest standards of quality.
• Ability to influence and drive change across functional teams and at all levels of the organization.

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