Sr. Manager, Quality Assurance Stability

Requirements

• Provides management and oversight of product-specific stability programs; from study design through reporting and lifecycle management
• Defines and drives phase-appropriate, risk-based stability strategies aligned with development milestones, regulatory expectations, and business objectives
• Collaborates with CMC Analytical Sciences, Drug Product/Drug Substance (DP/DS), Regulatory, Quality, and CTO/CMO partners to design stability studies and support shelf-life extension initiatives
• Analyzes and interprets stability data to establish or revise shelf-life and retest periods, proactively identifying trends and risks to inform CMC strategies and regulatory updates
• Authors stability assessments to support expiration dating, retest periods, and global regulatory submissions
• Manages and oversees stability tasks at Contract Testing Organizations (CTOs) and Contract Manufacturing Organizations (CMOs)
• Partners with the CMC-analytical team to provide technical oversight of the stability protocols and data at the contract manufacturing/testing organizations.
• Manages stability studies and data in the internal stability management software
• Provides user training and support for the stability program
• Enters stability data and manages the cross-functional review
• Manages the review and approval of various internal stability documents used in current Good Manufacturing Practices (cGMP) ensuring accuracy and appropriate format according to procedures
• Ensures out-of-trend or atypical results are addressed and support any on-going investigations
• Performs data verification for regulatory filings and other stability reports
• Participates in cross-functional project team meetings to provide stability updates as needed
• Supports activities for change control, corrective actions, management review and metrics reporting
• Identifies preventive action & continuous improvement opportunities
• Creates and maintains stability SOPs to facilitate continuous improvement
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements as applicable
• Adheres to all department and company-wide policies regarding conduct, performance, and procedures
• Provides oversight and direction to direct and indirect reports, as applicable (if assigned in the future), in accordance with the organization’s policies and procedures.

Benefits

• 401k match
• healthcare coverage
• ESPP
• annual bonus
• equity grant