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Director, Quality - Good Clinical Practices

Company: ElevateBio
Location: Waltham
Posted on: September 12, 2020

Job Description:

Director, Quality - Good Clinical Practices Title: Director, Quality - Good Clinical Practices

Location: Waltham, MA

Reports to: Vice President, Quality Assurance

The Role:

The Director of GCP QA will be responsible for strategic and operational management of the cell and gene therapy GCP QA activities. Reporting to VP of Quality, this individual will have primary responsibility for QA oversight of GCP activities at ElevateBio and its portfolio companies, contract research organizations and Investigator Sites to ensure that outsourced third parties are compliant and prepared for potential Sponsor and Regulatory Inspections and to ensure that the appropriate processes, systems, and activities are in place and performed to ensure the safety of our clinical patients. This is an excellent opportunity to develop the GCP QA function at ElevateBio and ensure high quality execution of clinical trials from first in human through commercial market authorization.

Here’s What You’ll Do:

Lead development, implementation, and maintenance of GCP Quality Systems and SOPs

Manage cross functional relationships with internal and external stakeholders and be the QA representative to clinical project teams

Assure through audits that non-clinical CROs, clinical CROs, clinical sites and supporting services are operating in compliance with ElevateBio’s quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services

Train and mentor staff on global GCP regulations and guidances

Lead preparations for Clinical Operations (corporate and third-party) inspection-readiness

Lead and manage GCP Inspections on behalf of ElevateBio

Participate in CAPA management process including direct or indirect implementation of actions resulting from observations/quality issues, reviewing and approving CAPA responses, etc.

Establish metrics and report the state of GCP Quality and compliance of clinical trials to senior management

Ensure Clinical Operations activities are compliant with cGCP, FDA, ICH, EMA regulations and guidelines and industry standards

Review key safety, clinical and regulatory documents

Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study and

Keep abreast of industry developments forthcoming regulations, guidance, best practices, etc.

Requirements:

BA/BS required, with a preference in the sciences, nursing or clinical scientific discipline

Minimum of 10+ years of experience in pharmaceutical drug development, with the majority in the field of clinical QA (GCP) in the biopharmaceutical industry

Excellent knowledge of Global GCP regulations and industry standards

Requires experience leading document review (Source data verification) initiatives

Ability to foster effective relationships with vendors, investigators and colleagues

Direct experience in managing Health Authority GCP Inspections

Ability to communicate and work independently with scientific/technical personnel

Periodic travel on assignment to investigator sites and CROs (approximately 10-20 % of time)

Excellent knowledge of Global GCP regulations and industry standards

Excellent organizational skills

Experience in cell and gene therapy environment is a plus

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:

Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified 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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Would you require visa support or sponsorship to take a position with ElevateBio? *

Would you need to relocate in order to accept a position with ElevateBio? *

Keywords: ElevateBio, Waltham , Director, Quality - Good Clinical Practices, Other , Waltham, Massachusetts

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