Senior Director of Quality Assurance

4 weeks ago

Étreux, Hauts-de-France, United States AVEO Oncology Full time
Job Summary:

The Senior Director of Quality Assurance at AVEO Oncology is responsible for leading quality operations and strategic leadership, ensuring compliance with US, EU, and other applicable regional regulations. This role requires a high level of expertise in the industry, with a focus on quality strategic leadership and compliance activities related to the cGMP manufacture and release of AVEO products.

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.

Key Responsibilities:
  • 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.
  • 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.
  • 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.
  • 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.
Requirements:
  • 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.
  • 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.
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.

  • Director of Quality Assurance

    4 weeks ago

    Étreux, Hauts-de-France, United States ICON Clinical Research Full time

    Director, Quality AssuranceICON Clinical Research is seeking a highly skilled Director, Quality Assurance to join our team. As a key member of our quality assurance department, you will play a pivotal role in ensuring the quality and compliance of our clinical trials.Key Responsibilities:Develop and implement quality assurance strategies and processes to...

  • Director of Quality Assurance

    4 weeks ago

    Étreux, Hauts-de-France, United States Pison Technology Full time

    Pison Technology is seeking a seasoned Director of Quality Assurance to spearhead the development and implementation of a comprehensive quality assurance strategy. This pivotal role involves driving quality initiatives across the organization, leading the QA team, and fostering a culture of quality and continuous improvement. The successful candidate will...

  • Director, Quality Assurance Lead

    3 weeks ago

    Étreux, Hauts-de-France, United States EngineeringUK Full time

    Job Title: Director, Quality AssuranceAbout the Role:We are seeking a highly experienced Director, Quality Assurance to join our team at EngineeringUK. As a key member of our quality assurance department, you will play a pivotal role in ensuring the quality and compliance of our clinical trials, interpreting regulatory requirements, and contributing to the...

  • Director of Pharmacovigilance and Quality Assurance

    1 month ago

    Étreux, Hauts-de-France, United States AVEO Oncology Full time

    Job Title: Director of Pharmacovigilance and Quality AssuranceAveo Oncology is seeking a highly skilled and experienced Director of Pharmacovigilance and Quality Assurance to join our team. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the highest standards of drug safety and compliance within our organization.Key...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Étreux, Hauts-de-France, United States Hydrogen Group Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Hydrogen Group. The successful candidate will work closely with our GDP Operational QA Management team to ensure the distribution of medicines in the USA complies with GDP and GMP requirements.Key ResponsibilitiesManage and maintain Quality Agreements, KPIs,...

  • Quality Assurance Manager

    4 weeks ago

    Étreux, Hauts-de-France, United States USPRO Full time

    Job Title: Quality Assurance ManagerJob Summary:The Quality Assurance Manager is responsible for leading the company's overall Quality Assurance and Food Safety program. This includes ensuring compliance with government food safety regulations and company standard operation procedures. The ideal candidate will have a strong background in food science,...

  • Senior Quality Assurance Manager

    3 weeks ago

    Étreux, Hauts-de-France, United States Gardner Resources Consulting Full time

    Job RequirementsWe are seeking a highly experienced Quality Assurance Manager to join our team at Gardner Resources Consulting. The ideal candidate will have a strong background in IT and quality assurance, with a minimum of 10 years of experience in the field.Key Responsibilities:Lead a team of quality assurance professionals in ensuring the delivery of...

  • Senior Auto Claims Examiner

    3 weeks ago

    Étreux, Hauts-de-France, United States Plymouth Rock Assurance Full time

    Senior Auto Claims ExaminerWe're seeking an experienced Senior Auto Claims Examiner to join our team at Plymouth Rock Assurance. As a key member of our claims organization, you'll play a crucial role in assessing coverage exposures, investigating accidents, and negotiating settlements. Your expertise will help ensure our policyholders receive the support...

  • Senior Financial Analyst

    4 weeks ago

    Étreux, Hauts-de-France, United States Plymouth Rock Assurance Full time

    About the RoleWe are seeking a highly skilled Senior Financial Analyst to join our team at Plymouth Rock Assurance Corporation. As a key member of our Finance team, you will play a critical role in supporting strategic business planning and financial analysis.Key ResponsibilitiesDevelop and maintain financial models and forecasts to support business...

  • Senior Financial Analyst

    4 weeks ago

    Étreux, Hauts-de-France, United States Plymouth Rock Assurance Full time

    Job SummaryThe Senior Financial Analyst will play a key role in supporting strategic business planning and financial analysis at Plymouth Rock Assurance Corporation. This position will work closely with stakeholders to generate term-end and mid-term reports, maintain a library of performance reports, and analyze results to drive insights into financial...

  • Senior Quality Assurance Manager

    4 weeks ago

    Étreux, Hauts-de-France, United States Gardner Resources Consulting Full time

    Gardner Resources Consulting is seeking a seasoned IT professional to fill the role of QA Manager. The ideal candidate will have a minimum of 10 years of total IT experience, with 5+ years of experience working in Quality Assurance as a manager or managing resources. Additionally, the candidate should have 2+ years of experience or exposure working on IT...

  • Director of Quality Operations

    4 weeks ago

    Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full time

    Job SummaryVertex Pharmaceuticals is seeking a highly experienced and skilled Director of Quality Operations to lead our Quality Operations team in ensuring the highest standards of quality in our oral solid dosage form manufacturing processes. As a key member of our Quality Leadership Team, you will be responsible for developing and implementing quality...

  • Advanced Quality Assurance Specialist

    2 weeks ago

    Étreux, Hauts-de-France, United States X4 Life Sciences Full time

    {"Role Overview": "As a Senior Quality Engineer, you will play a crucial role in ensuring the company’s products are safe, effective, and of the highest quality. You will develop and implement quality assurance processes throughout the product lifecycle and work closely with cross-functional teams to ensure compliance with regulatory requirements.", "Key...

  • Senior Manager/Associate Director, Quality Operations

    4 weeks ago

    Étreux, Hauts-de-France, United States Jobot Full time

    Job SummaryWe are seeking a highly experienced Senior Manager/Associate Director, Quality Operations to provide quality oversight for our biologics commercial programs. The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.Key ResponsibilitiesEnsure CMO compliance...

  • Senior Assurance Professional

    4 weeks ago

    Étreux, Hauts-de-France, United States Marcum LLP Full time

    Senior Assurance Professional Opportunity at Marcum LLPMarcum LLP is a leading national accounting and advisory services firm seeking a highly skilled Senior Assurance Professional to join our Boston office.As a Senior Assurance Professional, you will be responsible for leading audit engagements, overseeing staff, and ensuring the delivery of high-quality...

  • Senior Financial Analyst

    4 weeks ago

    Étreux, Hauts-de-France, United States Plymouth Rock Assurance Full time

    Job SummaryWe are seeking a highly skilled Senior Financial Analyst to join our team at Plymouth Rock Assurance. As a key member of our finance team, you will play a critical role in supporting strategic business planning and financial analysis.Key ResponsibilitiesDevelop and maintain financial models and reports to support business decision-making.Analyze...

  • Senior Financial Analyst

    3 weeks ago

    Étreux, Hauts-de-France, United States Plymouth Rock Assurance Full time

    Job SummaryWe are seeking a highly skilled Senior Financial Analyst to join our team at Plymouth Rock Assurance. As a key member of our finance department, you will play a critical role in supporting strategic business planning and financial analysis.Key ResponsibilitiesDevelop and maintain financial models and reports to support business...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Étreux, Hauts-de-France, United States Sonoma Consulting Full time

    QA Analyst Position at Sonoma ConsultingContractCandidates must be based in Massachusetts and attend an in-person interview. No remote interviews will be conducted.A minimum of 5 years of experience in quality assurance is required.Proficiency in integration using SQL is essential.Strong knowledge of the software development lifecycle (SDLC) and experience...

  • Senior Quality Assurance Analyst

    4 weeks ago

    Étreux, Hauts-de-France, United States RCM Life Sciences and IT Full time

    Job Title: Senior SQA Analyst - Veeva CRMRCM Life Sciences and IT is seeking a highly skilled Senior SQA Analyst to support implementation and upgrade projects around Veeva CRM and related technologies for our Life Sciences clients.Key Responsibilities:Develop and execute comprehensive test plans and strategies to ensure the quality of Veeva CRM...

  • Vice President of Quality Assurance

    3 weeks ago

    Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

    Job Title: Vice President of Quality AssuranceAbout the Role:We are seeking a highly experienced Vice President of Quality Assurance to lead our quality management system operations and ensure compliance with local, state, federal, and international regulations and standards associated with GxPs and quality systems in a fast-paced, primarily virtual...