Senior Manager/Associate Director, CMC Quality Assurance

  • Full Time (Salaried)
  • Boston, MA

Company:  Confidential

Job Title: Senior Manager/Associate Director, CMC Quality Assurance

Job Number: 36236

Location: Boston, MA

Job Description

A growing biotechnology company is seeking a Sr. Manager/Associate Director, CMC Quality Assurance to support Quality Management System (QMS) and Chemistry, Manufacturing, and Controls (CMC) activities. Reporting to the Head of Quality, this individual will help ensure compliance with GMP regulations and regulatory requirements across research, development, and commercial manufacturing operations. The ideal candidate will possess strong written and verbal communication skills and thrive in a dynamic, fast-paced environment.

Responsibilities

  • Manage training programs and records for employees in GxP environments, focusing on CMC GMP activities.

  • Review batch records, testing reports, method validation documents, and nonclinical study reports.

  • Review product specifications and support justification development.

  • Assist in CDMO/CRO evaluation and review quality agreements.

  • Support quality audits and regulatory inspections.

  • Review and approve change controls, deviations, investigations, CAPAs, and complaints.

  • Update CMC sections of regulatory and quality documents.

  • Collaborate across functions to address quality issues and ensure timely compliance reporting to management.

Required Skills

  • Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, or a related field, with 5–8 years of Quality Assurance experience in the biotechnology or pharmaceutical sector.

  • Experience supporting early-phase manufacturing with external partners such as CDMOs and CROs.

  • Familiarity with document management and training management systems within a QMS.

  • Background in vendor qualification and participation in compliance audits (preferred).

  • Experience with oligonucleotide-based therapeutics (preferred).

  • Strong knowledge of US and EU GMP regulatory requirements.

  • Proven ability to communicate and collaborate effectively with internal and external teams.

  • Willingness to travel domestically and internationally as needed.

  • Recognized as a team player with high professional integrity and strong work ethic.

  • Ability to perform effectively in a regulated, fast-paced environment.

 

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