Associate Director Quality Assurance

• Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
• Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
• Ensure required Quality resources are available to support commercial operations
• Inspection Readiness and Support
• Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
• Support site/network driven QA continuous improvement initiatives/activities
• Escalate significant quality issues to Quality Management in a timely manner
• Act as delegate to Quality Assurance Director when required to support business needs
• Support Drug Substance Alignment Meetings for Functional areas
• Providing guidance to the team
• Mentoring and Decision Making
• Ensuring alignment across the Quality Teams
• Supporting critical deviation resolution
• Ensuring timely closure of Quality records
• Ensuring timely review and approval of documentation
• Supporting the team in critical meetings
• Attend project and strategy meetings
• Meeting with the Functional Area/ Leadership monthly
• Plant QA/Manufacturing Support QA Huddle attendance
• SQDIP attendance ASM1
• Attend the Weekly Operational Meetings for ASM1
• Team one to one meetings
• Weekly Team Meeting
• XLT Meeting attendance
• Schedules tasks and ensure a level workload for the team
• Training oversight

• Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
• 10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
• Direct experience with bulk manufacturing of biopharmaceuticals preferred
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Your selection for this role will be subject to fulfilling the medical requirements of this job scope

Direct experience with bulk manufacturing of biopharmaceuticals preferred

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits