Crossbow Therapeutics, Inc., is a biotechnology company determined to improve the lives of people with cancer by unlocking the therapeutic potential of T-cell receptor (TCR)-mimetic antibodies. The company’s T-Bolt™ therapies are next-generation, easily assembled immunotherapies directed with high precision at previously unreachable cancer cell targets. Crossbow’s efficient and selective approach is designed to target the entire universe of cancer proteins, dramatically expanding the potential of antibody therapy to address many types of cancer.

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Join us on our bold quest to broaden the benefits of immunotherapy and improve the lives of people living with cancer. For more information, visit us at www.crossbowtx.com.

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About The Opportunity 

Crossbow is seeking an experienced, independent, and highly motivated Head of Quality Assurance to join our Development Team. The successful candidate will lead and oversee the QA function. This is a unique opportunity to establish the philosophy and culture for the QA function.

The individual will be responsible for managing the GMP and GCP operations to support the clinical development of Crossbow’s programs from early-stage discovery through commercialization. The incumbent will be expected to represent the QA department on project teams and to manage QA team members/vendors representing quality on project teams.  This position will be responsible for ensuring regulatory compliance across Crossbow’s clinical development programs.

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Key Responsibilities: 

• Develop, establish and maintain the QA programs, policies, and procedures to ensure cGMP compliance of clinical trial material, cGLP compliance of pre-clinical studies and cGCP compliance of clinical trials with internal standard operating procedures and applicable regulations.

• High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions

• Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards

• Deep understanding of large molecule and oncology drug product development

• Previous experience with building and implementing QA systems (QMS, RIM, LMS, etc.)

• Experience supporting products from early-stage development to post-approval

• Experience leading BIMO and PAI inspections

• Serve as escalation contact between QA vendors and contract facilities and Crossbow for Quality Assurance issues.

• Initially an individual contributor with an ability to hire and manage direct reports and mentor junior staff. 

• Understand global regulatory agency policies and guidance as they pertain to QA issues.

• Conduct QA review of manufacturing records, preclinical studies, clinical trial documentation and documents submitted to regulatory agencies.

• Release of finished goods for use in clinical trials and ultimately commercial sale.

• Support internal quality system including document control and training.

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Preferred qualifications and past experience: 

• At least 10+ years of biopharmaceutical / pharmaceutical experience with five years of experience in managing a QA function required

• Excellent knowledge of FDA, EU and other Global regulatory requirements and industry trends.

• Strong knowledge of cGMP, 21CFR part 11 and GCP regulations, practices, and trends pertaining to biopharmaceutical/ pharmaceutical product development, manufacturing, testing and clinical operations. 

• Familiarity with compliance and submission requirements of the FDA and other regulatory agencies.

 

To apply for this role: Send your resume directly to apply@crossbowtx.com

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Location: This position is a remote opportunity with periodic travel to the Crossbow location at 1030 Massachusetts Ave. Suite 210, Cambridge, Massachusetts and travel to clinical or manufacturing sites, as needed.

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To all agencies: All resumes submitted by search firms/employment agencies at Crossbow via email, the internet, or in any form and/or method will be deemed the sole property of Crossbow Therapeutics and no fee will be paid by Crossbow, unless such search firms/employment agencies were engaged by Crossbow for this position and a valid agreement is in place.

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A note about recruitment scams: Please be aware of potential recruitment scams, which can appear like legitimate work opportunities where the scammer pretends to work at Crossbow Therapeutics. To help protect yourself from those types of scams, please know that

• Crossbow will never ask for money or fees at any point during the interview process - if you are being asked to send money as part of your interaction, do not send money;

• Crossbow never asks applicants to communicate through Telegram or Skype - if you are being asked to download Telegram or Skype for a job interview, do not download;

• Crossbow employees will only email you from an official @crossbowtx.com email account.