Head of Quality Assurance

Company: GenScript ProBio
Location: Newark
Posted on: June 21, 2022

Job Description:

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 Responsibilities:

• 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 objectives.
• Provide cross-site quality leadership to quality systems lifecycle maintenance, raw material and final product release, supply chain, automation, manufacturing, validation and facility engineering.
• Apply Quality by Design principles to define a robust, integrated control strategies of the plasmid DNA platform manufacturing process.
• Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high quality products.
• Lead the preparation and execution of regulatory and client inspections, host audits and responsible for corrective action plans.
• Present updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities.
• 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 development activities.Qualifications:
• 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 remediation.
• 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 operating functions.
• Experience in CMC regulatory requirements for FDA and EMA is a plus.
• Direct management experience with successful track record of building, coaching and mentoring a high-performing team.
• Strong interpersonal, verbal, and written communication skills.SDL2017

Keywords: GenScript ProBio, Newark , Head of Quality Assurance, Other , Newark, New Jersey