JOB TITLE: Senior Director/ Director, Quality Assurance
DEPARTMENT: Quality Assurance
DATE PREPARED: September 10, 2024
JOB SUMMARY:
The Senior Director/ Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture and release of AVEO products. This position requires a high level of expertise in the industry, ensuring that all processes align with US, EU, and other applicable regional regulations including ICH Guidelines. The Senior Director will champion a culture of quality, ethics, and continuous improvement across the organization, driving key initiatives that enhance product life cycle management, quality, efficacy, and safety.
The incumbent will take a lead role in evaluating deviations and major investigations and will be responsible for disposition of clinical and commercial drug product to multiple jurisdictions.
The incumbent will work closely with the VP Quality Assurance in the implementation of Inspection Readiness programs. He/she will take a lead role in global change control ensuring regulatory compliance across multiple jurisdictions. The incumbent will be an active member of the Quality Leadership Team and will work with VP Quality Assurance and peers across the organization to define quality strategies and objectives.
The ideal candidate will possess a strategic mindset, with the ability to influence and lead cross-functional teams, manage complex projects, and drive organizational change. This role demands proactive leadership, exceptional communication skills, and the ability to foster strong relationships both internally and externally.
PRINCIPAL DUTIES:
- Strategic Quality Leadership:
- Develop and implement a robust Supplier Quality Management System that ensures all outsourced GMP operations are in compliance with all relevant regulations and industry standards.
- Provide strategic direction and oversight of Quality Assurance activities across all stages of product development and commercialization.
- Lead cross-functional initiatives to promote a culture of continuous improvement, quality excellence, and regulatory compliance.
- Serve as a key member of the Quality Leadership Team, contributing to the development of company-wide strategies and objectives.
- Quality Operations and Batch Disposition:
- Provides GMP Quality Assurance oversight of AVEO products manufactured at Contract Development Manufacturing Organizations (CDMOs).
- Provides leadership for significant deviation events or failure investigations at CDMOs and contract test labs. Leads implementation of corrective actions and quality system improvements.
- Leads QA evaluations of product quality at Material Review Board and Quality Management Review.
- Supplier Quality Systems and Compliance:
- Oversee the development and approval of quality documentation, including specifications, SOPs, and policies.
- Lead the Supplier Quality Management program for GMP operations, ensuring timely and appropriate vendor qualification, audits, and ongoing oversight.
- Manage the audit lifecycle, from planning and execution to report review, response evaluation, and closure.
- Ensure effective quality agreements with GMP vendors and oversee GMP quality operations at all facilities.
- Regulatory and Risk Management:
- Support process performance qualification (PPQ) activities, including the review of validation protocols/reports and risk assessments.
- Provide expert guidance on risk management strategies, vendor selection, monitoring, and remediation.
- Oversee the investigation and resolution of deviations, CAPAs, and complaints, ensuring timely closure and compliance with regulatory standards.
- Support and review relevant sections of regulatory submissions, including IND, IMPD, BLA, and NDA documents.
- Continuous Improvement and Innovation:
- Drive the continuous improvement of quality processes, systems, and operations, seeking opportunities for innovation and efficiency.
- Promote a quality mindset throughout the organization, ensuring that all activities align with the highest standards of quality and compliance.
- Lead initiatives to enhance the effectiveness of the QMS, including change control, deviation management, and CAPA systems.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
- Education & Experience:
- A minimum of 10 years GMP QA management experience in the Biotech/Pharmaceutical industry.
- Experience preparing for and hosting regulatory inspections. Previous experience in responding to regulatory inspections preferred.
- A BS degree in a scientific discipline is required; a post-graduate degree is highly desirable.
- Extensive knowledge of GMP guidelines, regulatory requirements, and industry best practices. Demonstrated knowledge of international regulatory requirements for biotech products and experience in disposition of biotech products to multiple jurisdictions.
- Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.
- Proven experience in leading quality assurance teams and managing complex quality systems.
- Leadership & Skills:
- Demonstrated ability to lead and influence cross-functional teams at a strategic level.
- Strong management skills, with a focus on process improvement and operational excellence.
- Exceptional verbal, written, and interpersonal communication skills.
- A creative and pragmatic approach to problem-solving, with the ability to drive solutions in a dynamic environment.
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
