Director / Senior Director, Quality Assurance
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 an experienced Director / Senior Director of Quality Assurance.
Working with the Vice President, CMC and Quality, this role is responsible for quality and compliance oversight of biologics programs as a Quality program lead. The position requires a solid understanding of biologics process/products, quality systems and compliance regulations as they relate to the manufacturing, testing, stability, scale-up and development of biologic products including cell banking, cell culture/fermentation, purification, and sterile drug product for clinical and eventual commercial use. This position requires identification and appropriate escalation of significant quality issues and compliance matters through management and compliance channels.
Responsibilities include, but are not limited to:
- As part of the Quality Assurance department provides quality support and oversight of Elevation Oncology team, including Good Manufacturing Practices (GMP) manufacturing, testing and disposition of biological GMP materials for use in clinical trials.
- Reviews and approves various biologic GMP documents including batch records, protocols/reports, investigations, period of use, dosing and administration instructions, product specifications, etc.
- Supports Vice President providing Quality oversight for biologic project-related investigations and issues and advises on policies and procedures. Contributes to the interpretation of GMPs for CDMO partners.
- Authors, reviews and negotiates Quality Agreements with partners and other established vendors.
- Communicates with and influences internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.
- Prepares documents and oversees documentation practices including SOPs, reports, vendor investigations, etc.
- Qualifies vendors by remote, audits, paper audits or on-site audits as proper. Maintains vendor quality program including clinical vendors.
- Manages the QA department workforce to appropriately achieve the department’s and company goals. Will have responsibility to perform tasks as well as oversee performance of others.
- Under direction of VP, CMC and Quality performs disposition of biologic materials manufactured by Vendors for use in clinical trials.
- Advises on late stage program strategy, including ICH Stability strategy, BLA strategy, Right First Time, etc.
- Act as a point of contact between Elevation Oncology and external suppliers, ensures communication, resolution and alignment regarding quality and compliance matters when clinical trial materials are manufactured and/or tested.
- Establishes self as a Subject Matter Expert (SME) for cGMP related quality and compliance and acts as a resource to Vice President and company.
- Prepares sections or tables for regulatory submissions.
- Trains new employees on SOPs and cGMP. Provides refresher cGMP training to company.
- Working with the CMO and ELV CMC management develop a PPQ plan. Work with the CMO team to oversee successful execution of PPQ activities.
- Providing internal process support for TT and process scale-up activities.
- Be the internal lead in development and oversight of hands-on process optimization and scale-up experiments. Collaborating with CMO Process Development in process scale-up efforts to go from small scale to intermediate and/or large scale to support commercial product.
- Assisting in preparation of campaign summary reports as required and provide internal review of CMO reports.
- Supporting and managing cGMP training program and provide training as needed.
- Work with VP, CMC and Quality and the PMO team to appropriately identify, report and remediate department and program risks
- Assuming additional responsibilities as assigned.
Required Skills and Qualifications
- Bachelor’s Degree or Master’s Degree with 10+ years relevant work experience (quality/technical/scientific) within the biopharmaceutical industry required OR PhD with 7+ years relevant work experience (quality/technical/scientific) within the biopharmaceutical industry required. Prior leadership experience required.
- Strong experience with Biologics is required. Quality Assurance experience with clinical product oversight at a CDMO is strongly preferred. Experience with biologics batch disposition, batch record review, release & stability data and manufacturing and laboratory deviations is required.
- Extensive knowledge of global GxP and regulatory requirements as related to the drug development process. GCP knowledge a plus.
- Team player with strong interpersonal, organizational, and communications skills are a must. Must be self-motivated, engaged and able to perform moderately complex tasks independently.
- Flexible and able to adapt to company growth and evolving responsibilities.
- Possess strategic and working knowledge of the biologic product life cycle from pre-IND through BLA, including experience with process and method validation and strategies.
- Experience with Phase 1-3 clinical trial material strongly preferred
- Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, communicating one on one or with larger groups, influencing external partners). Ability to independently problem-solve and make recommendations for solutions.
- May include moderate physical activity when performing on-site audits at partners.
Non-standard Work Schedule, Travel Or Environment Requirements
- 10 – 20% business travel may be required, includes travel for audits or meetings with partners.
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 firstname.lastname@example.org and tell us how you can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.