Manager/Sr. Manager, Quality Assurance

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 Quality Assurance Manager/Sr, Manager is responsible for independently representing Quality on product teams and program teams. This role will be participating in assigned projects from inception to successful completion, making coordinated use of processes and systems. The duties listed below are illustrations of the various type of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class.

Position Responsibilities:

• Lead/ facilitate internal quality tasks such as Deviations, CAPA, Change Control, Product Release
• Ensure CMO compliance with applicable global cGMP regulations, batch records, product registrations, quality agreements and data integrity standards
• Support QA batch record reviews and lot dispositions of cell banks, drug substance, drug product and finished goods per established procedures
• Lead quality aspects and provide support to our business partners on QA-related investigations, change controls, lot dispositions, and regulatory requests
• Lead quality aspects and provide support to CMOs in QA-related investigations, change controls, documentation and regulatory requests
• Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls and annual product quality reviews (APQRs)
• Review and approve controlled documents, including manufacturing and packaging master batch records, protocols and final reports
• Work with the Quality Systems and CMC teams to ensure quality and technical documentation is delivered to the internal archiving system
• Provide guidance, advice, and support for GMP quality and compliance matters
• Represent Quality as PIP at CMO’s as necessary to support production operations
• Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained
• Contribute to development and improvement of the Quality System as relevant, such as creation and updating of SOPs
• Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the QMS

Candidate Requirements:

• Bachelor’s degree in a science related field or equivalent experience
• At least 7-10 years of related GMP Quality experience.
• Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidance’s for Industry, EU regulations, and other standards.
• Strong proofreading and document formatting skills which must include processing of controlled documents (new documents, revision, obsolescence, etc.)
• Strong problem solving/analytical skills.
• Knowledge of MS Office® applications and spreadsheet programs such as Excel, Word, Power Point, and Microsoft Project.
• Excellent abilities with intermediate MS office concepts such as Word Styles, cross-references, keep with next, section breaks, freeze panes, header/footer and others
• The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.
• Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail
• The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
• Strong organizational skills and with the ability to handle multiple tasks.

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.