Vice President of Quality Assurance

JOB TITLE : Vice President Quality Assurance

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DEPARTMENT : Quality Assurance

REPORTS TO : COO

JOB SUMMARY :

Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.

The incumbent will lead the quality and related compliance activities for Aveo’s commercial product(s) and pipeline candidates (ranging from early to late-stage clinical trials).

The VP QA will direct all GxP Quality activities and ensure Aveo and its vendors are inspection ready, adhering to GLP, GCP, GPV, GDP, and GMP applicable regulations, company policies & procedures.

PRINCIPAL DUTIES :

• Lead and manage a high performing quality staff designed to meet the technical and compliance requirements of an established and growing company.
• Lead the overall GxP compliance programs for the enterprise.
• Oversee the inspection readiness, risk management, and metrics & reporting programs.
• Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
• Lead and manage computer system / cloud based validation and GAMP5 activities.
• Direct the maintenance of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GXP regulations.
• Proactively oversee AVEO’s outsourced GxP activities to ensure consistent quality and compliance.
• Oversight and review of partnerships / relationships with CDMO / CMO / CTL / CROs and where appropriate, manage these relationships through quality agreements.
• Lead the organization’s ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
• Ensure proper management for the creation, review and modification of controlled documentation (SOPs, forms, quality agreements, controlled lists, etc.).
• Lead the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external clinical, safety, quality, and regulatory standards.
• Ensure establishment and maintenance of company wide training matrix.
• Develop, manage and monitor adherence to the overall Quality budget.
• Foster a culture that values innovation, continuous improvement, and personal accountability in interactions with direct reports and others.

REQUIRED QUALIFICATIONS / EXPERIENCE (BASIC QUALIFICATIONS) :

• BA / BS in Life Sciences or related discipline. Advanced degree a plus.
• Minimum 15-20 years of experience in biotech / pharmaceutical industry; Minimum 10 years at a senior management level.
• Experience with working with and qualifying external vendors.
• Strong project management skills.
• Ability to problem-solve and provide guidance across a broad range of topics.
• Broad industry experience and technical background across GxP encompassing Production, Quality Assurance, Clinical Development and Quality Control.
• Should have an excellent understanding of Quality requirements in both the US and EU, or wherever AVEO products may be marketed / distributed.
• Successful track record of positive regulatory inspection outcomes and project / system implementations.
• Exceptional interpersonal skills including relationship building, conflict resolution and verbal and written communication are essential in this collaborative work 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.

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