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Quality Assurance Manager

  • Location

    Watertown, MA, United States

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    $130,000 - $150,000

  • Contact:

    Callum Sparkes

  • Contact email:

    callum.sparkes@catalystcareers.com

  • Job ref:

    60359

  • Published:

    5 days ago

  • Expiry date:

    2021-09-14

  • Consultant:

    Callum Sparkes

A great opportunity to be part of a small and high performing Quality team that has their breakthrough pharmaceutical product on course to be successfully submitted. Joining an existing highly experienced team, you will have the autonomy to lead the quality function from a pharmaceutical perspective on QMS, audit, compliance, supplier quality, and QC validations.

Core Responsibilities:
  • Understand and implement all quality procedures with regards to GMP, ICH, and FDA requirements/guidelines.
  • Review and approve Master and executed Batch Records for Drug Substance and Drug Product, stability protocols and reports, and specifications.
  • Be in the front room during FDA inspections for NDA submissions and planned audits.
  • Communication of findings to vendors responsible for the listed records and ensuring corrected documentation is received.
  • Review all documentation for release of API and drug product for use in clinical and nonclinical studies.
  • Liaise with all suppliers on overcoming CAPA, Deviation and Change Control issues that they may have.

Experience Required to be considered:

  • 8+ years' experience within quality in the pharmaceutical/bio-pharmaceutical environment
  • Drug supplier audit experience and knowledge of ICH Q3, Q7, Q9.
  • Fluent with QMS Deviation, CAPA, NCR experience required, with eQMS experience highly preferred.
  • Experience reviewing drug specifications SOP approvals and editing required FDA submission experience preferred
Please be advised that only those who are able to work in the United States without sponsorship are able to be considered at this point.