Director, GMP Quality Assurance
- 200 Cambridge Park Dr, Cambridge, MA 02140, USA
Precision therapeutics for genetically defined diseases. Real solutions for real challenges.
Who We Are
Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, CGT9486 (formerly PLX9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.
The Director, GMP Quality Assurance (QA) will support by leading GMP/GLP QA oversight of development activities required at all stages of Cogent’s products’ life cycle. In this position, the incumbent will be actively involved in executing the cGMP QA strategy by participating in program teams, contributing to risk-based assessments, providing QA support to foster cross-functional partnerships, and implementing regulatory intelligence processes. This role will be involved in review of regulatory submissions, contribute to inspection readiness efforts and Quality Management System (QMS) activities including procedural development, metrics tracking, and other process improvements. Additionally, the Director, GMP QA will lead and manage quality with external CDMOs, oversee execution of internal audit plans, review reports and track corrective actions.
What You Will Do:
- Lead the cGMP QA Strategy
- Author and revise SOPs to ensure a robust Quality Systems
- Implement and manage the supplier qualification program
- Lead Quality Assurance compliance programs including change control, deviation/investigation/CAPA, risk management, complaints, etc.
- Oversee cGMP QA at CDMOs for the manufacturing, testing and packaging of clinical material for all stages of development
- Support GMP/GLP compliance and alliance activities with vendors and business partners and own Quality Agreement creation and revisions
- Review regulatory submission documentation
- Lead Inspection Readiness efforts
- Build and foster cross-functional partnerships throughout the organization
- Perform Quality metrics tracking and reporting
- Own, facilitate and oversee audits, deviations and CAPAs
- Serve as the primary point of contact for QA controlled documents (i.e. SOPs, WIs, etc.) and QA training and as the subject matter expert for these topics during audits and inspections
- Contribute to commercial readiness preparations internally and at cGMP CDMOs.
- Lead QA activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits
- Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
- Manage and develop QA staff and contractors
What You Bring:
- Bachelor’s Degree in Chemistry, Biology, related life science, or equivalent work experience in a scientific or technical discipline. Master’s degree preferred
- Must have a minimum of 10 years of experience within the biotech or Pharmaceutical industry working in cGPM Quality functions.
- cGMP experience overseeing early and late stage, small molecule development
- Experience overseeing GMP quality activities with external partners (CDMOs), including
- Demonstrated analytical and process skills
- Effective communication, consulting, customer service and problem-solving skills
- Must be detail oriented, capability to meet deadlines
- Strong interpersonal skills and ability to interact with all levels of the organization
Cambridge, MA: Our Boston office is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.
Boulder, CO: We are in the process of building a second location in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location, which will serve as the future home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits.
- Cogent is an equal opportunity employer
- Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals