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AlloVir - Head of Quality Assurance

Company: ElevateBio
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Title: Head of Quality Assurance - AlloVir

Location: Cambridge

Reports to: SVP, Technical Operations

The Role:

The Head of Quality Assurance is responsible for the strengthening and further development and execution of the Company’s quality assurance program and systems, in support of all therapeutic development and manufacturing activities, directing cGxP quality related activities across the organization to support global regulatory submissions (NDA/MAA, etc) and ultimately commercial launch of products. The Head of Quality will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. The successful candidate will drive, promote and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.

Responsibilities:

Ensure that AlloVir’s Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities

Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement

Be a champion for continuous improvement in all aspects of total quality management through a well-trained team, streamlined business processes, and appropriate structured quality operations

Ensure products manufactured at CDMOs meet company quality standards and government regulations

Counsel, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance

Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management

Serve as an escalation point for corporate quality issues

Serve as primary GMP contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency

Conduct all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines

Qualifications:

Bachelor's degree or Master's degree in related Life Sciences discipline

15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical industry

Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products

Familiar with ICHQ9 principles and has demonstrated the ability to utilize Quality Risk Management principles in everyday practice.

A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members

Join the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening virus-associated diseases in patients with severely weakened immune systems. Over many years, AlloVir’s world-leading scientists have developed a highly innovative pipeline of allogeneic, off-the-shelf, T-cell therapies being studied to treat and prevent many devastating and life-threatening virus-associated diseases. The company’s lead product, Viralym-M, an investigational cell therapy to treat active virus-associated diseases, including from BK hemorrhagic cystitis, cytomegalovirus, adenovirus, Epstein-Barr virus, JC virus and human herpesvirus 6. AlloVir’s technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.

Join AlloVir to help advance the development of this innovative technology platform and multiple mid- and late-stage clinical trials in order to help severely immunocompromised patients. AlloVir is part of the ElevateBio-family of companies with access to ElevateBio BaseCamp’s industry-leading, centralized cell and gene therapy manufacturing capabilities. By joining AlloVir, you’ll be able to not only advance innovative science but also a part of a truly new business model for advancing cell and gene therapies.

AlloVir 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. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Keywords: ElevateBio, Cambridge , AlloVir - Head of Quality Assurance, Other , Cambridge, Massachusetts

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