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Job Summary

Alchemy is partnering with a multinational biotech organisation in their search for an Early Phase Quality Assurance Manager – Pharmato join their team in Bend, OR.

The Early Phase QA Manager will be responsible for designing, maintaining and sustaining phase appropriate key quality functions for Early Phase pharmaceutical production including development, pre-clinical and clinical activities in a CRO/CDMO environment.

Responsibilities

  • In depth technical knowledge of organizational management, cGMP quality systems, US and non-US cGMP regulations and FDA, EU and ICH guidelines with practical implications and applications for an early phase clinical setting
  • Design and implement new phase appropriate cGMP systems (policy, procedures, work instructions etc.) to support early phase clinical offering
  • Develops staff in key quality systems and regulatory guidelines
  • Escalate issues to the quality management and other Site leadership that could pose any compliance risks to the site
  • Ensure R&D, product development and clinical procedures, equipment, facilities, people adequately meet regulatory requirements and are audit ready
  • Provides guidance to the QA (Quality Assurance) team in the development, implementation and management of quality systems
  • Approve Certificate of Compliance for early phase products
  • Assure a steady flow of QA approval of early phase products
  • Work with internal and external customers, US and non-US regulatory agencies and partners on quality and compliance issues
  • Advise management on potential issues, and ensuring the implementation of the appropriate actions
Requirements
  • Quality Assurance Management experience gained in a Pharmaceutical/Biotech or related FDA regulated industry is required
  • Experience with a CRO (contract research organization)/CDMO (contract development and manufacturing organization) organization or closely interacting with a CRO/CDMO preferred
  • Experience with clinical cGMP facilities, processing equipment, laboratory testing, manufacturing, and understanding of the technical, regulatory, development and commercial aspects of pharmaceutical products
  • Proven record of successful interaction with regulatory agencies, internal and external auditing groups, and preparation of all required correspondence
  • Prior cGMP experience and Early Phase Product Development experience
  • Bachelor’s degree, ideally in a relevant field
Relocation support is available for this role.

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Job Summary


Reference: 11559

Location: Bend, Oregon, United States

Salary: Competitive

Contract: Permanent

Posted: 10 Dec 2020