GMP QA Manager

Boston Permanent USD125,000 - USD126,000
  • Help transform patient care
  • Join a rapidly growing biotech company

About Our Client

Early stage biotech company targeting cancer medicine through radiotherapies.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

  • Represent QA on project teams, meetings, and special assignments by identifying and providing input on quality assurance issues.
  • Review and approve complex manufacturing batch production and analysis records, including analytical method validation, specification development and approval, manufacturing, drug product, starting materials, intermediates, process validation, stability programs and other supporting activities in support of final product disposition, in accordance with specifications and SOPs.
  • Work with CMOs and CMC groups to for clinical and/or commercial use.
  • Provide quality assurance expertise and recommendations in a professional and collaborative manner to internal and external stakeholders.
  • Provide onsite quality oversight critical operations at manufacturers or other vendors, as needed.
  • Generate targeted metrics for management review.
  • Review quality agreements in support of GMP activities.

The Successful Applicant

  • Bachelors degree in chemitry, biology, engineering or related field
  • 5-10 years in QA setting
  • Experience in Diagnostics
  • Radiopharmacuetical experience
  • GMP auditing experience
  • Incorporating risk management into quality systems
  • Ability to manage multiple projects in a fast-paced environment



What's on Offer

  • Competetive base salary plus possible bonus
  • Benfits package
  • Fast growth opportunity



Contact
Meghan Landry
Quote job ref
JN-122021-4543701

Job summary

Sector
Sub Sector
Location
Contract Type
Consultant name
Meghan Landry
Job Reference
JN-122021-4543701