Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
The Senior Manager of GCP/GVP/GLP Quality is responsible member of the R&D GxP QA team and provides QA expertise, consultation and oversight with regard to GxP activities for branded biotechnology and pharmaceutical development products.
As part of an emerging biotech organization, the Sr Manager of GCP/GLP/GVP QA will assist in the development and maturation of a Phase appropriate Quality Management System (QMS). This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate. The incumbent will support, conduct and/or interpret internal and external GCP/GLP/GVP audits with a focus on risk mitigation and management as well as process improvement. The Sr Manager of GCP/GLP/GVP will also be part of cross functional NDA/BLA filing diligence, inspection readiness and inspection support.
Position Responsibilities:
- Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP, GVP and GLP compliance. Assists in identifying and communicating clinical trial-related risks and opportunities for process improvement. Reviews study-related documents and plans.
- Participates in the development and approval for the CQA audit schedule including the contracting of PV, GLP and GCP audits;
- Responsible for developing, tracking and managing periodic management reports including key Clinical and PV Compliance and QA metrics;
- Manages, participates and/or provides support during complex audits and regulatory inspections;
- Independently determines approach to complex compliance issues and reports findings to management with recommendations for resolution and verifies appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented;
- Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding risk assessments and compliance issues and provides compliance guidance, training and mentorship;
- Maintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organization;
- Participates and leads in the development and delivery of GCP, GLP, GVP training internally;
- Represents CQA in internal presentations on quality issues, initiatives and projects
- Works on significant and unique issues where analysis of situations or data requires an in-depth knowledge of the clinical research and PV processes as well as an evaluation of intangibles.
- Supports Quality Management System (QMS) including, QA review/approval of deviations, CAPAs and change controls, Drafts, reviews, and approves SOPs.
- Review and analyze study site and/or vendor audit reports and provide support to oversee open CAPAs to closure including the evaluation of the need for subsequent effectiveness checks.
- Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
- Communicate any serious or critical compliance risks noted from these activities to senior management (manage reports of EU GCP Serious Breaches and/or reports of Serious or Persistent non-compliances)
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
Candidate Requirements:
- Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations, and ICH guidelines gained through direct experience in the drug development process gained through working for a branded biotech or pharmaceutical company
- Working knowledge of supporting preparation, submission, and pre-approval activities, specifically in relation to GCP, GLP and PV Quality, for global regulatory filings for branded pharmaceutical/biotech products.
- Ability to influence others as part of a collaborative team and negotiate effective solutions to complex problems; strong interpersonal and social skills.
- Minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training.
- Bachelor's degree in a relevant field, such as Life Sciences or Healthcare required. Advanced degree preferred.
- Authorization to work in the US for a company.
- Candidates located within commuting distance of the Cullinan Cambridge MA office preferred. Candidates on East Coast or Central US considered.
- Ability to travel up to 25%
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
