Director/Sr Director GXP Quality Systems
Cambridge, MA
QA /
Remote /
Hybrid
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 Director/Sr Director, Quality Systems will be a key member of the Quality Assurance Leadership Team (QALT) with broad responsibilities. The successful candidate will help to create a quality management infrastructure that is compliant, effective, efficient and agile and that supports a rapidly growing business model with complex and diverse product lines. S/he will provide quality management oversight for elements of the Cullinan Therapeutics Quality Management System (QMS), which includes corrective and preventive action, training, document controls, for all aspects including identification and escalation of quality system issues. Provide strategic guidance regarding the establishment and monitoring of quality metrics for executive review to determine health of QMS and lead the team in continuous improvement and planning for growth activities as needed. S/he will grow, develop and manage team to interface and support all GXP regulatory compliance requirements of the company.
Position Responsibilities:
- Establishes formal programs, guidelines and procedures related to QMS areas of responsibilities.
- Directs quality oversight of compliance and quality systems activities including Quality Risk Management, Data Integrity, Training, Audits and Inspections, Change Control, and Document and Records Management.
- Works with stakeholders and/or Learning Management staff to develop and deploy an optimized role based GXP compliance training program that includes monitoring and reporting of training compliance metrics.
- Works with cross functional leadership to implement best practices for change control documents.
- Works with stakeholders to ensure Cullinan Quality Systems are compliant and effective for local, regional and corporate business needs as well as regional regulatory requirements.
- Responsible for facilitation/management of regulatory inspections/external audits and related compliance activities.
- Acts as Head of the GXP audits program and defines audit programs across the GXP space that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.
- Manages responses and leads efforts for all CAPA/lessons learned from audits and inspections.
- Working with the QALT and stakeholders, helps to define the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of Cullinan quality system(s).
- Provide training and consulting to internal customers on GXP Quality System regulatory compliance.
- Partner across the company to drive standardization of Quality Systems.
- Establish programs to effectively monitor and assess the Cullinan quality system through key performance indicators, metrics and scorecards.
- Work to ensure the timely identification, escalation and corrective actions resulting from Management Review and Quality System reviews.
Candidate Requirements:
- Expertise in GXP compliance, Quality Systems and global GXP regulations.
- Proven record with the successful implementation and management of the Quality System in a sterile, biologics or cell therapy biotech environment.
- Strong working knowledge and experience with Quality Risk Management.
- Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and timely mitigate unfavorable quality compliance trends.
- Demonstrated strong interpersonal skills and a passion for developing teams and people to their highest potential.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Demonstrated ability to lead through influence and expertly communicate program updates in both oral and written formats in a cross-functional matrix organization.
- Demonstrated knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as 21 CFR and ICH is required.
- Demonstrated experience in managing external regulatory body inspections.
- Demonstrated leadership of CAPA Programs
- A working knowledge of project management tools and techniques.
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment.
- A minimum of 12 years’ experience in a Pharmaceutical/Biotech setting, with a minimum of 8 years in a quality assurance or compliance management role is required OR a Masters’ degree and a minimum of 10 years’ experience in a Pharmaceutical/Biotech setting, with a minimum of 8 years in a quality assurance or compliance management role is preferred.
- Required Education And Training
- BS/MS in relevant Science or Engineering discipline
- Minimum of 7 years of experience with being Manager of Managers (tiered leadership).
- Minimum of 10 years of experience with biologics health authority inspections experience.
- Minimum of 5 years of experience with leading health authority inspections.
- Minimum of 10 years of experience within a Quality System and Compliance or equivalent Quality roles.
- Preferred Skills And Experience
- Experience implementing quality management systems (QMS) in a large molecule and cell therapy development environment preferred.
- Experience developing the QMS strategy to transition from clinical stage to commercial stage company preferred
- Experience with eQMS platform implementation preferred.
- Six Sigma, RAC, ASQ certification is 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.
