Associate Director, Quality Assurance

Cogent Biosciences Cambridge , MA 02138

Posted 2 months ago

Company Description

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, PLX9486 (expected to be named CGT9486 in the future), 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 PLX9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.

Job Description

The Associate Director, R&D Quality Assurance (QA) will support the organization by providing GCP/GVP/GCLP/GLP QA oversight for research and development activities required at all stages of Unum's products' life cycle. In this position, the incumbent will be actively involved in executing the R&D QA strategy by participating in R&D program teams, contributing to risk-based assessments, providing R&D QA support to foster cross-functional partnerships, and implementing regulatory intelligence processes. This role will be involved in review of MAA/BLA submissions, contribute to inspection readiness efforts and Quality Management System (QMS) activities including procedural development, metrics tracking, and other process improvements. Additionally, the Associate Director, R&D QA will lead and manage quality with external CDMOs, oversee execution of GMP/GCP and internal audit plans, review reports and track corrective actions

What You Will Do

  • Lead the R&D QA Strategy implementation

  • Represent R&D QA at program team meetings

  • Perform R&D QA risk assessments

  • Build and foster cross-functional partnerships throughout the organization

  • Review IND submissions and other R&D submission documentation

  • Lead delegated GCP/GVP/GCLP/GLP Inspection Readiness efforts

  • Provide procedural development and other process improvements. Where there is cross-reference and/or cross functionality with other bluebird bio functional controlled procedures, ensure harmonization for alignment and compliance

  • Perform GCP/GVP/GCLP/GLP metrics tracking and reporting

  • Own, facilitate and oversee audits, deviations and CAPAs

  • Serve as the primary point of contact for R&D QA controlled documents (i.e. SOPs, WIs, etc.) and R&D QA training and as the subject matter expert for these topics during audits and inspections

  • Monitor GCP/GCLP/GVP/GLP non-conformance trends and communicate this information to management with proposed remediation actions

  • Contribute to commercial readiness preparations internally and at GMP vendors

  • Lead R&D QA activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits

  • Manage the development, review and approval of lifecycle validation master plans, protocols and reports working with CDMOs

  • Track GCP/GCLP/GVP/GLP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments

  • Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks

  • Support GCP/GCLP/GVP/GLP compliance and alliance activities with vendors and business partners and lead Quality Agreement creation and revision

Qualifications

What You Bring

  • Bachelor's Degree or equivalent work experience in a scientific or technical discipline

  • Must have a minimum of 10 years of experience in the areas of GXP regulations with a minimum of 7 years of experience in a GMP, GCP or GVP quality and compliance role

  • Quality and compliance background, preferably related to GMP/GCP/GVP

  • 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

Additional Information

Our Location

Cogent 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.

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

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Associate Director, Quality Assurance

Cogent Biosciences