Senior Manager Quality Assurance Operations
3 days ago
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.
Location
This role is located in Cambridge, MA, and requires local candidates only.
About the Company
Marengo Therapeutics, Inc. is a rapidly growing biopharmaceutical company with a strong focus on 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.
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