Senior Manager, QA Operations and Lot Disposition

Role Summary

The Quality Senior Manager is responsible for oversight and management of Akebia’s global manufacturing network for all stages of a growing clinical and commercial pipeline. The incumbent will review manufacturing and analytical records to support disposition of clinical and commercial drug substance, drug product, and finished goods, and manage related Quality records such as deviations, change controls, and CAPAs. Builds a strong, high-performing Quality Culture in a fast-paced organization.

Responsibilities

• Oversee and execute Quality disposition process for commercial and clinical products manufactured at CMOs, ensuring release in accordance with approvals, authorizations, standards, procedures, and GMP guidelines.
• Review and approve Master Batch Records and executed batch records.
• Review and approve analytical testing as part of batch record review.
• Disposition of drug substance batches and drug product lots.
• Ensure data accuracy in Quality databases and report disposition metrics.
• Identify, initiate, and implement process and system improvements.
• Manage QA assessment/review/approval for deviations, change controls, and CAPA workflows.
• Lead QA communications with CMO quality partners to address observations/quality concerns.
• Participate in regulatory and partner inspections as subject matter expert.
• Create/revise SOPs and provide training as required.
• Perform other QA duties and ad hoc projects as required.

Qualifications

• Required: Bachelor‚Äôs Degree
• 7+ years in the biotechnology or pharmaceutical industry
• 5+ years in Quality Assurance with experience in both paper and electronic systems including 21 CFR Part 11 compliance
• 5+ years experience in pharmaceutical batch record review and product disposition

Preferred Qualifications

• Bachelor‚Äôs Degree in Chemistry, Biology, Life Sciences
• Experience with global CMOs
• Experience maintaining a Quality infrastructure in a fast-paced growing company
• Strong verbal and written communication and interpersonal skills
• Ability to work well in a team or independently
• Experience with US and EU Quality requirements and a broad QA GMP knowledge
• Technical writing skills
• Critical thinking and problem-solving skills
• Proficient in Microsoft Office
• Strong organization and project management skills
• Direct supervisory experience

Education

• Bachelor‚Äôs Degree (required); in Chemistry, Biology, Life Sciences preferred