Manager, Quality Assurance GCP
Remote
Technology Operations – Quality /
Full-Time /
Remote
Who We Are
Cogent Biosciences is a publicly traded 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, bezuclastinib (CGT9486), 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 (SM), 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. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Our Team
https://cogent.culturehq.com
This is an exciting opportunity to join our growing Quality department. The Manager, Quality Assurance GCP provides quality oversight for the company’s clinical projects, primarily through the conduct of vendor audit activities as well as investigator site audits. Additionally, the position provides QA support and consulting to internal study teams, working closely with relevant functional areas. The position develops, plans, and executes audits to ensure compliance with regulatory standards and company policies and procedures. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.
Responsibilities
- Develops, plans, and executes audits of Contract Research Organizations (CROs) and other service providers as well as clinical investigator sites ensuring compliance with all Food and Drug Administration, World Health Organization, and other applicable guidelines for regulatory standards, as well as company policies/procedures and contractual obligations.
- Collaborates with Clinical Operations to ensure clinical studies are conducted in compliance with all applicable regulatory standards and ensures company readiness for regulatory inspections
- Manages quality events and corrective/preventive actions.
- Contributes to technical document review in support of clinical development programs.
- Provides leadership in continuous improvement of good clinical practices.
- Conduct internal audits of Trial Master Files for GCP compliance.
- Collaborate with a cross-functional and interactive team
- Ability to travel to vendor and clinical sites to conduct audits as needed (up to 30% of time, but able to direct your schedule as long as business needs are met)
Qualifications
- Bachelor’s Degree in Science (required), Preferably in Pharmaceutical Sciences or Technology, Life Sciences, etc.
- Minimum of 5-7 years of relevant experience in a pharmaceutical clinical quality assurance environment with a minimum of two years of vendor auditing experience
- Demonstrated knowledge of applicable regulations and ICH GCP guidelines
- Self-motivated and demonstrated success in working with cross-functional teams
- Must be detail oriented with proven abilities to meet deadlines
- Excellent interpersonal, written, and verbal communication skills
$130,000 - $150,000 a year
Target Bonus: 10-15%
*Exact compensation may vary based on skills, experience, and location.
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the 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), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
