Sr. Manager, Quality Assurance Stability
Xencor
4 hours ago
Remote friendly (Pasadena, CA)
United States
Operations
Summary:
The Senior Manager, Quality Assurance Stability leads and executes end-to-end, product-specific stability programs across the lifecycle, from study design and implementation through data management, reporting, and shelf-life oversight. Develops phase-appropriate, risk-based stability strategies; designs, manages, and oversees stability studies with cross-functional partners and external CMOs/CTOs. Analyzes stability data to establish/revise shelf-life and retest periods; authors stability assessments for global submissions; identifies trends and risks to support CMC and regulatory strategies.
Job Duties:
- Manage and oversee product-specific stability programs (study design through reporting and lifecycle management)
- Define and drive phase-appropriate, risk-based stability strategies aligned with milestones, regulatory expectations, and business objectives
- Collaborate with CMC Analytical Sciences, DP/DS, Regulatory, Quality, and CTO/CMO partners to design studies and support shelf-life extension
- Analyze/interprete stability data to set or revise shelf-life and retest periods; proactively identify trends/risks
- Author stability assessments for expiration dating, retest periods, and global regulatory submissions
- Manage/oversee stability tasks at CTOs and CMOs; provide technical oversight of stability protocols/data
- Manage stability studies and data in internal stability management software; enter data and manage cross-functional review
- Provide user training/support for the stability program
- Review/approve internal stability documents for cGMP accuracy and proper format
- Address out-of-trend/atypical results and support investigations
- Perform data verification for regulatory filings and stability reports
- Support change control, corrective actions, management review, and metrics reporting; identify preventive action/continuous improvement
- Create/maintain stability SOPs and ensure SOPs define required task steps
- Maintain knowledge of cGMP and global regulatory standards; adhere to company policies
- (If assigned) provide oversight and direction to direct/indirect reports
Education/Experience/Skills:
- Bachelor’s degree in a scientific discipline
- 10+ years of Quality Assurance/QC/Analytical or CMC development experience in biopharmaceutical industry
- 4+ years of stability program experience (prior project management preferred)
- Core statistics: trend analysis, regression modeling, confidence intervals, variability
- Ability to communicate complex scientific/medical/program issues (written and verbal)
- Ability to partner across research, pre-clinical, manufacturing, quality, regulatory, and clinical teams
- Flexibility/adaptability for a fast-paced small biotech
- Demonstrate competencies per leadership competency model
- Ability to coach/supervise others
Travel/Work Location:
- Occasional travel (including between Pasadena and San Diego offices)
- Full-time onsite at worksite; hybrid with 2 days/week onsite from San Diego office
Benefits/Compensation & Application:
- Expected base salary range: $150,000–$175,000
- Eligible for annual bonus and equity grant
- Total rewards: 401k match, healthcare coverage, ESPP, and other benefits
- For more information: https://xencor.com/careers/
The Senior Manager, Quality Assurance Stability leads and executes end-to-end, product-specific stability programs across the lifecycle, from study design and implementation through data management, reporting, and shelf-life oversight. Develops phase-appropriate, risk-based stability strategies; designs, manages, and oversees stability studies with cross-functional partners and external CMOs/CTOs. Analyzes stability data to establish/revise shelf-life and retest periods; authors stability assessments for global submissions; identifies trends and risks to support CMC and regulatory strategies.
Job Duties:
- Manage and oversee product-specific stability programs (study design through reporting and lifecycle management)
- Define and drive phase-appropriate, risk-based stability strategies aligned with milestones, regulatory expectations, and business objectives
- Collaborate with CMC Analytical Sciences, DP/DS, Regulatory, Quality, and CTO/CMO partners to design studies and support shelf-life extension
- Analyze/interprete stability data to set or revise shelf-life and retest periods; proactively identify trends/risks
- Author stability assessments for expiration dating, retest periods, and global regulatory submissions
- Manage/oversee stability tasks at CTOs and CMOs; provide technical oversight of stability protocols/data
- Manage stability studies and data in internal stability management software; enter data and manage cross-functional review
- Provide user training/support for the stability program
- Review/approve internal stability documents for cGMP accuracy and proper format
- Address out-of-trend/atypical results and support investigations
- Perform data verification for regulatory filings and stability reports
- Support change control, corrective actions, management review, and metrics reporting; identify preventive action/continuous improvement
- Create/maintain stability SOPs and ensure SOPs define required task steps
- Maintain knowledge of cGMP and global regulatory standards; adhere to company policies
- (If assigned) provide oversight and direction to direct/indirect reports
Education/Experience/Skills:
- Bachelor’s degree in a scientific discipline
- 10+ years of Quality Assurance/QC/Analytical or CMC development experience in biopharmaceutical industry
- 4+ years of stability program experience (prior project management preferred)
- Core statistics: trend analysis, regression modeling, confidence intervals, variability
- Ability to communicate complex scientific/medical/program issues (written and verbal)
- Ability to partner across research, pre-clinical, manufacturing, quality, regulatory, and clinical teams
- Flexibility/adaptability for a fast-paced small biotech
- Demonstrate competencies per leadership competency model
- Ability to coach/supervise others
Travel/Work Location:
- Occasional travel (including between Pasadena and San Diego offices)
- Full-time onsite at worksite; hybrid with 2 days/week onsite from San Diego office
Benefits/Compensation & Application:
- Expected base salary range: $150,000–$175,000
- Eligible for annual bonus and equity grant
- Total rewards: 401k match, healthcare coverage, ESPP, and other benefits
- For more information: https://xencor.com/careers/