Vice President, Quality Assurance
Cullinan Oncology
Quality Assurance
Cambridge, MA, USA
Posted on Friday, November 10, 2023
Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.
We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.
Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.
Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.
As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.
Summary:
Reporting to the Chief Technical Operations Officer, the Vice President/Head of Qualitywill be an experienced and adaptive Quality leader, responsible for developing and leading a world-class Quality organization, enabling the continuedadvancement of our clinical therapies. This leader will be accountable for creating a scalable and sustainable quality organization aligned with the growth of the company and advancement of our portfolio. The Head of Quality will have responsibility for the end-to-end quality, including the leadership of all GxP functions, driving a culture of quality excellence within the organization.
The role is based out of the Cambridge Massachusetts office with flexibility for hybrid and/or remote work options.
Position Responsibilities:
- Develop and execute global quality strategies aligned with the company's goals, ensuring that quality standards and processes are integrated into all stages of product development.
- Identify and assess potential quality risks and develop risk mitigation plans to proactively address issues that could impact product development.
- Oversee quality aspects related to third-party suppliers and vendors, ensuring that they meet the company's quality and compliance standards.
- Lead efforts to maintain compliance with FDA and other relevant regulatory bodies, staying current with the latest regulatory requirements and guiding the company in meeting these standards.
- Establish, implement, and maintain quality systems and procedures to ensure adherence to GxP (and other relevant quality standards) at all levels of the organization.
- Build and manage a high-performing quality team, providing mentorship, coaching, and professional development opportunities to ensure a culture of continuous improvement and quality excellence, driving initiatives to enhance quality processes and systems.
- Prepare for and manage external regulatory audits and inspections, ensuring readiness and successful outcomes.
- Assure that the appropriate suite of Standard Operating Procedures is in place and optimally maintained to support critical drug development activities as well as our vendor relationships with external CRO or CMOs.
- Ensures a robust, risk-based, phase-appropriate audit program is successfully realized throughout our vendor network.
- Develop key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
Candidate Requirements:
- Bachelor's degree in a relevant field (advanced degree preferred).
- A minimum of 15+ years of experience in quality leadership roles within the pharmaceutical or biotech industry, with a focus on oncology products and with smaller biopharmaceutical companies in early- to mid-stage development.
- Strong knowledge of FDA and international regulatory requirements.
- Multidiscipline expertise and experience in a GCP and GMP as well as familiarity with non-Clinical requirements and responsibilities.
- Proven experience in implementing quality systems and strategies.
- Excellent leadership and team management skills.
- Strong analytical, problem-solving, and communication abilities.
- Ability to adapt to a dynamic, fast-paced environment.
- Experience with GxP requirements for clinical and commercial products and with the US and international regulatory authority inspection requirements and first-hand experience hosting regulatory inspections.
- Experience leading a quality team at a company developing both large and small molecule therapeutics.
Cullinan Oncology 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.