Vice President, Quality
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers has an opening for experienced Quality Leader.
Reporting to the Chief Executive Officer, the VP of Quality is a key member of the leadership team and will be responsible for the strategic development and execution of Elevation Oncology’s Quality Program and Quality Management System supporting our portfolio of clinical stage therapeutics in accordance with global quality regulations, preparing the company for commercial operations. The VP of Quality will lead and grow the quality team, collaborate across the organization on all quality matters and build and develop strong relationships externally to support quality activities and responsibilities.
- Lead the Quality organization
- Define the strategic direction for the Quality Organization and Quality Objectives for the Company in alignment with corporate and portfolio strategy. Map and design key quality processes
- Develop, propose, and implement quality strategy, plans, and culture through collaboration, training, metrics, and risk-based thinking
- Oversee phase appropriate development of Company’s Quality Management System (QMS).
- Responsible for final decisions on all quality related matters, in conjunction with Qualified Person(s) for EU product distribution, if necessary
- Oversee GxP initiatives to support a portfolio of global clinical stage programs with oversight of CMO and CRO vendors
- Provide leadership and mentorship to the Quality team, including building the team and its capabilities to meet the needs of the business
- Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner
- Champion continuous improvement in all aspects of total quality management through a well-trained team, through streamlined business processes, and with appropriately structured quality operations
- Ensure both on-going compliance and inspection readiness across GxP functional areas
- Organize Quality Governance Meetings to report Quality metrics, compliance trends, and any areas of risk with associated mitigation plans
- Oversee the establishment and maintenance of phase appropriate quality systems including but not limited to: change control, training, contract service providers (CSP) including quality agreements, batch record approval and Certificates of Analysis, quality trend reports
- Oversee audit function for the company and for CSPs involved in investigational drug product manufacturing, commercial manufacturing, nonclinical studies, and clinical studies that includes a CSP qualification program and a master audit schedule.
- Implement phase appropriate audit plans in order to ensure that investigational drug supply and clinical research studies meet required quality standards and are in compliance with the requirements of SOPs, study protocols, relevant regulations and ICH/GCP guidelines.
Required Skills & Qualifications:
- Advanced degree in a scientific discipline.
- 15+ years of experience in the pharmaceutical or biotech industry. Oncology drug development experience required.
- Demonstrated track record of successful regulatory filings, NDA filings and drug approval.
- Regulatory leadership and team management experience required.
- Expert knowledge of US GXP regulations and quality guidelines required, including industry best practices and standards in Quality Assurance, knowledge of EU and Asia Pacific regulatory requirements highly desired.
- Solid experience with CMC, clinical, and nonclinical development, and Regulatory submissions.
- In-depth understanding of the drug development, product commercialization, and life cycle management processes.
- Demonstrated proficiency in departmental budgeting, organizing, and planning.
- Demonstrated leadership competencies and strategic business perspective are required.
Up to 40% domestic and international travel may be required. Must be located within and authorized to work in the United States today and in the future.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to email@example.com and tell us how you would. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.
Search Firms and Agency Representatives: Elevation Oncology is not accepting unsolicited resumes from search firms or agencies for any job posting. Resumes submitted to any employee of Elevation Oncology by any search firm or agency without an applicable contract in place will be the property of Elevation Oncology and no fee will be paid.