Cullinan Oncology
Sr. Manager/Associate Director, Quality Management Systems
Job Posted 5 Days Ago
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Oversees development and improvement of quality management systems ensuring compliance with regulatory standards, managing vendors, and presenting performance metrics to senior management.
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/Associate Director, Quality Management Systems is responsible for overseeing the development, implementation and continuous improvement of the quality management systems (QMS) to ensure compliance with cGxP regulatory standards and company policies. They will work collaboratively with functional leads to identify business needs, leverage the full potential of existing technologies to streamline complex processes, and serve as a direct interface for solution management, with the goal of sustaining a compliant, robust and phase-appropriate Quality Management System.
Position Responsibilities:
- Partner with business leadership and other key stakeholders to identify continuous improvement opportunities to enhance the value and efficiency of existing quality management systems.
- Develop, and ensure the effective integration of, new quality system procedures and processes to comply with phase-appropriate cGxP regulations throughout the product development lifecycle and promote sustained quality performance.
- Manage quality system vendors to ensure timely fulfillment of deliverables.
- Manage and maintain the supplier qualification, internal and external audit programs in accordance with industry standards and procedural requirements.
- Prepare and present quality system performance metrics to senior management, highlighting key trends, risks and improvement areas.
- Work collaboratively with the IT business partners to ensure electronic systems are properly on-boarded, managed and validated in accordance with procedural and 21 CFR Part 11 requirements.
- Overall project management, administration and implementation of electronic quality system enhancements.
- Develop training material(s), and facilitate instructor-led training sessions, for quality management systems and processes.
Candidate Requirements:
- Bachelor’s degree in Life Sciences or a related field
- Minimum of eight (8) years of experience in the pharmaceutical industry, with at least five (5) years of experience with Veeva system applications.
- Strong understanding and experience with regulatory guidelines and standards (FDA, ISO, GxP, etc.).
- Prior experience managing and implementing QMS software and tools
- Ability to work collaboratively with cross-functional teams and senior leadership
- Strong project management experiences preferred
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.
Top Skills
Electronic Quality System Enhancements
Veeva System Applications
Cullinan Oncology Cambridge, Massachusetts, USA Office
1 Main St, Cambridge, Massachusetts, United States, 02142
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