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 be responsible for the review of manufacturing and analytical records to support disposition of both clinical and commercial drug substance (DS), drug product (DP) and Finished Goods (FG). Additionally, the incumbent will be responsible for the management and oversight of related Quality records such as deviations, change controls, and CAPAs arising from activities associated with Akebia’s manufacturing network for both clinical and commercial products. The Sr. Manager, QA Operations and Lot Disposition will help to build a strong, high-performing Quality Culture in a fast-paced, growing Quality organization.

Responsibilities

• Responsible for the oversight and execution of Quality disposition process for commercial and clinical products manufactured at CMOs ensuring products are released in accordance with Registered Approvals or Marketing Authorizations, their Manufacturing Authorizations, Clients Global Quality Standards and Procedures, and current Good Manufacturing Practice guidelines
• Perform and manage the QA review and approval of Master Batch Records and executed batch records.
• Manage the QA review and approval of analytical testing as part of the batch record review process.
• Perform disposition of drug substance batches and drug product lots
• Ensure accuracy of data used in Quality databases.
• Provide and report metric information associated with the disposition of materials
• Identify, initiate, and implement process and system improvements.
• Perform and manage the QA assessment/review/approval for deviations, change controls, and CAPA workflows.
• Lead the QA communication process with CMO quality partners to address observations and/or quality concerns.
• Participate in Regulatory and partner inspections as subject matter expert
• Create/revise SOPs or other documents and provide training, as required.
• Perform other QA related duties and ad hoc projects, as required.

Qualifications

• Required: Bachelor‚Äôs Degree
• Required: 7+ years of experience in the biotechnology or pharmaceutical industry
• Required: 5+ years in Quality Assurance with experience in both paper and electronic based systems including 21 CFR Part 11 compliance
• Required: 5+ years experience in pharmaceutical batch record review and product disposition
• Preferred: Bachelor‚Äôs Degree in Chemistry, Biology, Life Sciences
• Preferred: Experience working with global CMOs
• Preferred: Experience maintaining a Quality infrastructure in a fast-paced growing company
• Preferred: Strong verbal and written communication and interpersonal skills
• Preferred: Ability to work in a team or independently
• Preferred: Experience with US and EU QA GMP requirements; technical writing skills
• Preferred: Critical thinking and problem-solving skills
• Preferred: Proficiency in Microsoft Office; strong organizational and project management skills
• Preferred: Direct experience in a supervisory role

Skills

• Quality Assurance
• GMP compliance
• Batch record review
• Deviation, change control, and CAPA management
• CMO coordination and inspections
• SOP creation and training
• Data integrity and QA systems

Education

• Bachelor‚Äôs Degree (required)

Additional Requirements

• Location: Cambridge, MA