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Job Details

Head of Quality Assurance and Regulatory Affairs

Location
Cambridge, MA, United States

Posted on
Dec 31, 2020

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Profile

The Company

**MEMBERS ONLY**SIGN UP NOW***., Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases. **MEMBERS ONLY**SIGN UP NOW***. is a high growth company and is listed on NASDAQ (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.

**MEMBERS ONLY**SIGN UP NOW***. is building a world-class team of highly motivated, dedicated scientists to help us advance our research and development programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.

Key Responsibilities

  • Build the company's quality systems. Formulate the company's GMP, GLP and GCP compliance strategies and provide advice and support for all clinical development programs within **MEMBERS ONLY**SIGN UP NOW***..
  • Lead the creation the company's IND, IMPD and CTA regulatory filings. Manage the annual updates and maintenance of these filings and their amendments.
  • Act as the company's regulatory agent and be the company's main point of contact with the FDA, EMA and other global regulatory agencies.
  • Assess all GMP, GLP and GCP compliance risks to **MEMBERS ONLY**SIGN UP NOW***.'s clinical development programs and develop and implement risk mitigation measures. Develop and implement standards, policies and procedures for GMP, GLP and GCP compliance.
  • Partner with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all **MEMBERS ONLY**SIGN UP NOW***. clinical development programs by providing guidance and serving as an expert in the interpretation of GMP, ICH, GLP and GCP regulatory requirements and expectations.
  • Plan and lead GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks. Report audit findings to management with recommendations for resolution. Ensure that all audit resolution items have been implemented and documented.
  • Participate in the evaluation and selection of contract manufacturing sites, analytical testing sites, clinical storage and distribution depots, CROs and other service providers used to support **MEMBERS ONLY**SIGN UP NOW***.'s clinical development programs.
  • Manage the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports and essential clinical study documents.

Requirements
  • A bachelor's degree in a scientific discipline with at least 15-20 years' experience or an advanced degree in a scientific discipline with at least 15 years of QA / regulatory affairs experience with injectable protein based biologic products. Advanced scientific degree preferred.
  • Hands-on experience building and managing quality systems for sterile biologics products to support global clinical trials.
  • In-depth knowledge of and ability to interpret and apply FDA, ICH and GLP regulations, guidelines and best practices.
  • Experience acting as a regulatory agent to support IND, IMPD, CTA and other regulatory filings.
  • Experience in planning and conducting GMP, GLP and GCP audits.
  • Ability to use a phase appropriate approach to assess product quality and regulatory compliance during the review and disposition process.
  • Experience developing and maintaining Quality Management Systems such as documentation and record management, change control, deviations, investigations, training and CAPA programs.
  • Experience reviewing and auditing study-related documentation such as non-clinical and clinical study report, and investigator brochures.
  • Ability to travel domestically and internationally to vendor and partner sites as needed to support product development activities and corporate partnerships.
  • Strong team player with demonstrated track records of success in a cross-functional team and a fast-moving entrepreneurial environment.
  • Excellent, organizational, oral and written communication skills. Ability to lead through influence to negotiate effective solutions with other stakeholders within the company and with external partners.
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