Head of Quality Engineering (Sr. Manager / Assoc. Director)
Posted on: February 19, 2021
Title: Head of Quality Engineering (Sr. Manager / Assoc.
Reports To: Vice President of Quality Operations
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.
- 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
- 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
- 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
- Participate in writing, reviewing and approving CMC sections of
US and international clinical trial applications, regulatory
question responses, supplemental biologics license applications and
- Instill a Quality Risk Management culture. Proactively
identify, assess, and mitigate quality, operational, and
organizational risks; escalate key risks and issues.
- 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
- Expertise in commercial cGMP drug regulations; working
knowledge of product development and clinical manufacturing
- 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
- Strong written and oral communication skills both internal and
- Ability to function in a rapidly changing environment & handle
- Ability to travel as needed to support on-site manufacturing
- 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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