This job has expired

Head of Quality Assurance

Employer
Scientific Search
Location
New York City, NY
Closing date
Jan 27, 2023

View more

Sector
Pharmaceutical, Quality Assurance
Organization Type
Corporate
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Head of Quality Assurance
Therapeutic Area:
Oncology
Location: Hybrid Onsite in NYC
Salary Range: Depending on Experience and Level $250-310k base plus bonus and equity.

Our biopharmaceutical client has tasked Scientific Search in finding them an Executive Director or VP Of Quality Assurance. The ED/VP, Quality will define, shape, and drive our client's Quality Strategy. This position will provide quality systems, and network technical support, and ensure network interconnectivity across the manufacturing supply chain. This role will build and manage a world class team of high-performance quality associates and work in close contact internally with the development, Operations, and Quality Control groups, and externally with CDMOs to ensure best practices and consistent delivery on company milestones.

Responsibilities:
  • Ownership, oversight, and implementation of Quality Systems across the External Manufacturing (ExM) network in concern with Quality & Compliance Excellence.
  • Establish quality roadmap and deliverables to take the company's lead asset through validation, global filing, approval, and launch while also advancing the pipeline products
  • Responsible for management of the day-to-day activities in scope of ExM Quality inclusive of Product Quality Complaints, Deviations, CAPAs, APQRs, Training Management, and Quality Risk Management.
  • Ensures ExM Quality is fully aligned with external regulations, and the Quality Management Systems of our CDMO partners.
  • Supports audits, Health Authority inspections and associated logistics when required, including the assistance in the generation of HA Responses and CAPAs.
  • Establish and manage the governance of a Quality Council to manage CDMO compliance and supply risks.
  • Establish ExM Quality KPIs, raising potential risks along with risk mitigation activities
  • Ensures CMC/Regulatory Compliance for mAb Intermediates, Drug Substance and Drug Product operations, including oversight of change management and product restrictions to control disposition of products subject to change approval.

Requirements:
  • Advanced degree in science of pharmaceutical related fields (Chemistry, Pharmacy, Biology, and Chemical Engineering) preferred.
  • Minimum of 10 years of Biopharmaceutical experience in commercial manufacturing environments.
  • Experience in developing talent, managing change, engaging, and motivating people and developing a quality organization and work structures
  • Knows and understands Quality compliance processes and regulations, e.g. cGMP/GDP regulations.
  • Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.

For immediate consideration please email Tom O'Hanlon at tom@scientificsearch.com
Be sure to check out all of our other current openings at

#LI-TO1
  • Type: Direct Hire
  • Category: Biopharmaceutical Company
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