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Quality Operations Manager
2 months ago
About Us:
We are an innovative therapeutics organization with a market-approved drug, utilizing advancements in B-cell biology to create groundbreaking treatments for patients.
Why Consider This Opportunity?
- Attractive Salary
- Annual Performance Bonus
- Equity Options (RSUs)
- 401k Retirement Plan
- Flexible Remote Work
- Comprehensive Health Benefits
- Established Commercial Drug Portfolio
Position Overview:
We are seeking a Quality Operations Manager/Senior Manager to oversee quality assurance for our biologics commercial and clinical development initiatives.
Key Responsibilities:
- Supervise Contract Manufacturing Organizations (CMOs) to ensure compliance with regulatory standards, product registrations, and quality agreements.
- Conduct batch record evaluations and product lot assessments.
- Manage and analyze product-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
- Review and authorize controlled documents, including clinical and commercial manufacturing protocols and final reports.
- Assist internal and external partners with DSCSA and distribution processes.
- Collaborate with Quality Systems and CMC teams to ensure proper documentation is archived internally.
- Facilitate onboarding of new suppliers, manage supplier qualifications, and maintain Quality Agreements.
- Provide expertise and support for GMP quality and compliance matters.
- Represent Quality in PIP at CMOs as needed to support production activities.
- Travel up to 10% for domestic and international engagements, including visits to CMOs.
Qualifications:
- Bachelor’s degree in life sciences or a related discipline.
- Minimum of 5 years of experience in GMP Quality or Manufacturing within the biopharma/biologics/pharma sector.
- In-depth understanding of GMP regulations; experience with regulatory inspections is advantageous.
- Proven experience in managing clinical phases through to commercial and lifecycle management.
- Familiarity with contract manufacturing oversight.
- Proficient in electronic Quality Management Systems (QMS) such as Veeva.
- Knowledge of cell-based or gene therapies is preferred.
- Understanding of medical devices and combination products is a plus.
- Awareness of DSCSA requirements is beneficial.
- Exceptional attention to detail, organizational, and time management skills.
- Strong written and verbal communication abilities.
We look forward to your interest in this position.