Quality Assurance Manager

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Cullinan Oncology

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Oncology

11 - 50

💰 $10M Post-IPO Equity on 2022-03

Description

•Cullinan Therapeutics is a biopharmaceutical company focused on establishing new standards of patient care. •We have a diversified portfolio inhibiting key drivers of disease and using the immune system. •The Quality Assurance Manager/Sr, Manager represents Quality on product teams and program teams. •Participates in projects from inception to successful completion using coordinated processes and systems.

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.