Manager, Quality Assurance
About The Position
This role will report to the Director of Quality and operate across departments, supporting regulated activities and studies. This new role will support CMC development and clinical disposition activities for Tango’s development programs. Tango works in a matrixed, outsourced model where compliance and inspection readiness are key to our programs as we advance through the development cycle. The Manager, Quality Assurance will provide GMP QA oversight for Tango’s CMC development programs and clinical supply activities. This role partners cross-functionally with Technical Operations, Regulatory, and external manufacturing partners to ensure compliance with global GMP requirements while supporting the advancement of investigational therapies through clinical development.
Requirements
- Bachelor's Degree in Chemistry, Biology, Engineering or related field plus 5 years pharma manufacturing, packaging or laboratory experience
- At least 5 years of direct QA/compliance experience working in biotechnology, pharmaceutical, laboratory, CRO or CMO environment
- Strong knowledge of global GMP regulations (FDA, EMA, ICH) applicable to investigational drug development
- Experience providing QA oversight of drug product development across the pharmaceutical lifecycle Thorough understanding of creation/ review/approval of GMP documents such as specifications, test methods, stability protocols, batch records, and investigations
- Ability to collaborate effectively in a matrixed, cross-functional, and global environment
- Strong oral/written communication skills
- Capable of analyzing a wide variety of information and data to make management decisions regarding potential risks associated with product quality or regulatory compliance
- Able to establish professional relationships and rapport with internal and external peers and experience working collaboratively with teams in a complex, matrixed and global environment
- Strong attention to detail and commitment to maintaining high quality and compliance standards
- Strong project management and organizational skills, with the ability to manage multiple concurrent priorities
Responsibilities
- Review batch documentation and dispositions materials for use in clinical trials
- Lead & manage strategic GMP QA activities associated with Tango CMC development programs
- Ensure compliance with regulations related to manufacturing, testing, packaging & distribution of investigational drug product and active pharmaceutical ingredients. Identify compliance gaps and propose solutions
- Execute and lead implementation of phase-appropriate quality guidance, review, and approval processes for product development programs across Phases 1–3
- Oversee projects independently, identifying, evaluating, and resolving product quality concerns in compliance with GMP requirements
- Identify trends related to development compounds, operations, etc.
- Ensure timely review, approval, and archival of GMP documentation and quality records
- Participate in GMP audits of CMOs, contract laboratories, and other vendors, providing recommendations regarding vendor qualification and continued use
- Mentor and support internal teams on GMP documentation, quality practices, and regulatory compliance
- Additional duties and responsibilities as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
