Summary:
This position is responsible for supporting the Head of QA with oversight of Verastem Quality Systems and QA activities in accordance with GXP requirements. This includes the development and implementation of procedures, policies, and systems to support commercial and clinical stage operations and to drive compliance with current regulations. Responsible for oversight of external GMP Quality operations at partner, commercial and clinical-stage CMOs for a biopharmaceutical company committed to accelerating the development and commercialization of targeted treatments to provide new options for patients battling cancer.
Responsibilities:
- Individual will help define and drive the Quality vision and mindset in close collaboration with the Head of Quality.
- Define clear Quality objectives and ensure progress and cross functional completion of responsibilities; use judgement to develop solutions and drive risk analysis and mitigation strategies.
- Partner closely with the Quality organization, Technical Operations, Supply Chain and CMO Sites to establish and maintain effective working relationships, meet project timelines, execute technical transfers, and other duties as necessary.
- Review batch records and analytical data for conformance to specifications and regulations. Disposition clinical stage batches for human use in a timely manner to ensure product availability for patients.
- Ensure change management program is used effectively for changes impacting GMP drug substance, drug product, finished goods and other GMP processes.
- Review and approve external product technical investigations and deviations associated with manufacturing operations.
- Establish strong interfaces with Technical Operations (CMC), Supply Chain, Clinical Operations, and Regulatory Affairs teams to address and resolve complex and routine activities while building positive relationships, fostering continuous improvement, and adding value.
- Develop and approve SOPs to further define the Quality System and ensure control over the quality vendor services and products.
- Lead cross-functional committees responsible for evaluating and approving specifications and materials for Verastem products (Specification Review Committee, Material Review Board).
- Actively support validation and implementation of new electronic Quality Systems (e.g., Veeva QualityDocs, Veeva QMS Systems, Learning Management System) across the organization.
- Assist in developing Quality plans and metrics to monitor QMS effectiveness and communicating results to senior management via management review.
- Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to cGMPs.
- Review regulatory filings and associated technical documents as needed.
- Participate in pre-approval and routine regulatory agency inspections.
- Visit CMO sites, as required.
- Additional responsibilities assigned by Head of Quality.
Qualifications:
- Bachelor's degree in a scientific field; advanced degree preferred.
- Minimum of 15+ years of Quality Assurance/Manufacturing Operations experience in pharmaceutical or biotech industry.
- In-depth knowledge of GMP and QA principles, practices and standards; through understanding of FDA, EMA and ICH quality regulations.
- Demonstrated excellence in attention to detail.
- Strong team player that has a customer service approach and is solution oriented. Works effectively and autonomously in a lean/flexible organization.
- Experience with Regulatory/Health Authority Inspections
- Excellent verbal and written communication skills to effectively communicate with colleagues and vendors.
The base salary range ($190,000 - $270,000) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
