Associate Director QA Operations Lead

3 days ago

Cambridge, Massachusetts, United States Marengo Therapeutics, Inc. Full time

About Marengo Therapeutics, Inc.

Marengo Therapeutics is a pioneering biopharmaceutical company dedicated to developing innovative therapeutics that activate the right immune response to promote lifelong protection against cancer. Our team is passionate about making a meaningful difference in the lives of patients and their loved ones.

Job Overview

We are seeking an experienced Associate Director/Director Quality Assurance Operations to join our growing team. This role will provide end-to-end phase-appropriate product quality, compliance management, and vendor oversight and management. The successful candidate will be responsible for establishing and maintaining appropriate development phase GMP/GLP compliance for material/product development, manufacture, testing, and stability.

Responsibilities

  • Establish and maintain appropriate development phase GMP/GLP compliance for material/product development, manufacture, testing, and stability.
  • Establish and approve material specifications, COA, and COC.
  • Material/product disposition activities.
  • Review and approval of testing documents, including method validation protocols, reports, and raw data.
  • Oversight and management of the material stability program and material shelf life.
  • Vendor qualification, management, and oversight.
  • Providing quality guidance and being accountable for the continuous development, execution, and administration of the phase-appropriate quality systems, including resolution of quality issues.
  • Provide support for regulatory filings, including IND, BLA, and regulatory updates.
  • Continuous improvement activities.

Requirements

  • Minimum of 10+ years of progressive, relevant experience in the biopharma or medical device industry required.
  • Bachelor of Science is required; MBA/advanced degree welcomed.
  • Minimum 8+ years of progressive, relevant experience in the biopharma or pharmaceutical industry required. Experience in a GMP Quality function at a Biotechnology or pharmaceutical organization.
  • Candidate should have 4+ years' experience in QA Operations/Material Disposition role.
  • In-depth understanding of quality principles and GMP/ICH/FDA/EU regulations presented by the global health authorities.
  • Good interpersonal skills and ability to work collaboratively and cross-functionally.
  • Vendor qualification and audit experience.
  • Experience with managing and overseeing vendors related to manufacturing, testing, label/pack, and distribution.
  • Ability to complete risk assessment and resolve product quality issues.
  • Experience with working with development and clinical phase material/product.
  • Technical knowledge of analytical method qualification and establishment of product specifications.
  • Excellent analytical skills and ability to gather information, perform risk analysis, and communicate issues in a simple way.

Salary Estimate

The estimated salary for this position is between $150,000 - $200,000 per year, depending on experience.

Benefits

We offer a comprehensive benefits package, including:

  • Competitive salary
  • Comprehensive health insurance
  • Dental and vision insurance
  • Flexible spending accounts
  • 401(k) plan
  • Short-term and long-term disability insurance
  • Life insurance
  • Parental leave

Work Environment

We are a dynamic and collaborative team, committed to making a positive impact in the lives of patients and their loved ones. We offer a fast-paced and challenging work environment, with opportunities for professional growth and development.

About Us

Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

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