Early Phase Quality Assurance Manager

Product Development, Early Phase, GMP
Full Time

Job Description

Early Phase Quality Assurance Manager

Bend, OR



As an Early Phase Quality Assurance Manager, you will be responsible for building, 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. 


Key responsibilities:

  • Exhibits technical depth in 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
  • Able to architect and implement new phase appropriate cGMP systems (policy, procedures, work instructions etc.) to support early phase clinical offering
  • Demonstrates record of successful interaction with regulatory agencies, internal and external auditing groups, and preparation of all required correspondence
  • Demonstrates experience with clinical cGMP facilities, processing equipment, laboratory testing, manufacturing, and understanding of the technical, regulatory, development and commercial aspects of pharmaceutical products
  • Develops staff in key quality systems and regulatory guidelines
  • Escalates issues to the quality management and other Site leadership that could pose any compliance risks to the site
  • Ensures 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
  • Approves Certificate of Compliance for early phase products
  • Assures a steady flow of QA approval of early phase products
  • Works with internal and external customers, US and non-US regulatory agencies and partners on quality and compliance issues
  • Advises management on potential issues, and ensuring the implementation of the appropriate actions


Key requirements:

  • Bachelor’s degree
  • Pharmaceutical/Biotechnology or related FDA (Federal Drug Administration) regulated industry experience is required
  • Quality Assurance Management Experience preferred
  • Experience with a CRO (contract research organization)/CDMO (contract development and manufacturing organization) organization or closely interacting with a CRO/CDMO preferred

Prior cGMP experience and Early Phase Product Development experience


For immediate consideration, kindly send a copy of your updated resume with contact number ASAP or Please feel free to reach out Vishnu Shanth at in case if you have any questions.


About Us:

ObjectWin Technology, Inc. is a rapidly growing Twenty year old Houston, TX headquartered corporation and specialized solution provider in the ERP, CRM, Web technologies and Systems Integration areas. We take great pride in hiring and retaining the highest caliber of technical talent. ObjectWin is expanding rapidly and we have been selected as 2009 Deloitte Technology Fast50 Texas company. We are looking for talented individuals with drive to carry us into the next phase of growth and beyond.


Note: ObjectWin Technology, Inc. is an Employment Opportunity Employer. Qualified applicants are considered for employment without regard to age, race, color, religion, sex, national origin, sexual orientation, disability or veteran status.

Dice Id : objectwi
Position Id : MK11122002
Originally Posted : 1 year ago
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