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Head of Quality Engineering (Sr. Manager / Assoc. Director)

Company: AlloVir
Location: Cambridge
Posted on: February 19, 2021

Job Description:



Title: Head of Quality Engineering (Sr. Manager / Assoc. Director)

Location: Cambridge

Reports To: Vice President of Quality Operations

The Role:

This position is responsible for quality oversight of AlloVir's CMC technical activities in support of supply of both clinical and commercial phase Cell Therapies according to current Good manufacturing Practices (cGMP) including FDA, EMA and ICH guidelines and industry best practices. The incumbent will partner with internal and external teams to ensure high levels of quality for all change controls, deviation and lab investigations, CAPAs, process development studies, commissioning and qualification activities, and computer system and process validation. Reporting to the Head of Quality Operations, he/she provides the results-oriented leadership required to build a world-class cell therapy organization and establish a robust and efficient Quality Management System (QMS). This position requires an individual capable of partnering across the organization to establish an innovative cell therapy manufacturing supply chain and deliver transformative medicine to patients.

Responsibilities:

  • Provide quality oversight to Technology Transfers across CMO network ensuring alignment with approved regulatory documents ensuring that processes and practices are compliant with global current good manufacturing practices (cGMP) and ICH guidelines.
  • Recruit and develop team to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognitions practices.
  • Establish department and individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and quality metrics.
  • Define and administer assigned QMS elements; drive continuous improvement culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
  • Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations.
  • Instill a Quality Risk Management culture. Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.

    Qualifications:

    • Bachelor's degree in a science or technical field and 8-10 years of related biopharmaceutical GMP work experience or Master's degree and 6-8 years of work experience. Minimum of 2 years of leading teams.
    • Expertise in commercial cGMP drug regulations; working knowledge of product development and clinical manufacturing requirements.
    • Preferred experience in cell and/or gene therapy.
    • Demonstrated ability to analyze, interpret and compile data, define problems, establish facts, draw valid conclusions and make timely fact based decisions. Extraordinary attention to detail.
    • Strong written and oral communication skills both internal and external.
    • Ability to function in a rapidly changing environment & handle multiple priorities.
    • Ability to travel as needed to support on-site manufacturing oversight.
    • Ability to gown and navigate cGMP manufacturing areas.

      Why join AlloVir?

      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.

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Keywords: AlloVir, Cambridge , Head of Quality Engineering (Sr. Manager / Assoc. Director), Executive , Cambridge, Massachusetts

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