CAPA Manager

Responsibilities

• Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines
• Oversee day-to-day operation of the CAPA Quality System and facilitate recurring meetings
• Lead and facilitate investigations for deviations using tools like 5 Whys, Fishbone, and FMEA
• Review and approve CAPA documentation for completeness and accuracy
• Train and qualify deviation authors, CAPA, and Continuous Improvement owners
• Trend CAPA metrics and perform root cause analysis on system performance
• Prepare and present metrics and trend reports for management review and regulatory inspections
• Support internal, client, and regulatory audits related to CAPA activities
• Partner with Manufacturing, Technical Services, Quality, and Engineering teams

Requirements

• Bachelor’s degree in a science-related field with 5+ years of pharmaceutical or medical device experience (including management)
• OR Master’s degree with 3+ years of pharmaceutical or medical device experience
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines
• Proven experience managing CAPA systems and leading investigations
• Ability to analyze quality data and identify systemic issues
• Familiarity with electronic quality management systems (e.g., Veeva, TrackWise)
• Proficiency in Microsoft Office Suite

Preferred Qualifications

• Experience with data visualization or reporting tools such as Power BI
• Advanced Excel functions

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.