Head of Quality Assurance
Company: GenScript ProBio
Posted on: June 21, 2022
Role Description:The position reports to the Vice President of
GenScript ProBio, US Site Head, and is responsible for the
strategic development and operational management of site's QMS
(Quality Management System), and accountable for ensuring
consistent and harmonized execution of the systems, including
facility/utility/equipment qualification, quality systems
establishment and maintenance, raw material management, production
process support, product release, deviation and CAPA management,
change management, and risk management across the US manufacturing
site. There is a great opportunity to lead and evolve this function
within a CDMO business, to support a broad portfolio and advance
the manufacturing capabilities to deliver products to the client
projects that transform the lives of patients.Key
- Develop strategy of QMS and establish quality procedures to
support clinical and commercial GMP production at New Jersey site
based on corporate policies.
- Participate the recruitment of Quality Assurance team, retain
and develop talents, and provide leadership for a high performing
team to meet GMP compliance requirements and overall business
- Provide cross-site quality leadership to quality systems
lifecycle maintenance, raw material and final product release,
supply chain, automation, manufacturing, validation and facility
- Apply Quality by Design principles to define a robust,
integrated control strategies of the plasmid DNA platform
- Oversee and manage the execution of quality systems during
daily production activities to ensure the delivery of high quality
- Lead the preparation and execution of regulatory and client
inspections, host audits and responsible for corrective action
- Present updates to project or upper management teams on
progress and enforcement of quality improvement and manufacturing
- Review and approve technical protocols, reports and risk
assessments, and work to improve application and standardization of
phase appropriate processes and curricula.
- Up to 10% traveling to support CDMO projects or business
- Master's or Ph.D. degree, ideally in life sciences related
field or equivalent with 10+ years' experience in biotech
production environment with substantial management responsibility
within Quality Assurance. Experience with gene and cell therapy
products or recombinant plasmid DNA products highly desirable.
- Deep understanding and demonstrated working knowledge of Code
of Federal Regulations (CFRs), ICH guidance documents, EudraLex
Vol. 4, and other regulations that govern GXP compliance during
clinical development and commercialization of drug candidates.
- Expert knowledge of quality risk assessment and management
methodologies, including successful application and risk
- Proven track record in establishing a quality organization and
managing GMP Quality staff.
- Versed in phase appropriate practices of clinical vs.
commercial manufacturing requirements.
- Adept in building working relationship between QA and other
- Experience in CMC regulatory requirements for FDA and EMA is a
- Direct management experience with successful track record of
building, coaching and mentoring a high-performing team.
- Strong interpersonal, verbal, and written communication
Keywords: GenScript ProBio, Newark , Head of Quality Assurance, Other , Newark, New Jersey
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