Role OverviewThe Director of Sterility Assurance will lead the Aseptic Core Monitoring (ACM) program, develop technical acumen in direct reports, and oversee the execution of PCI's standard EMPQ and APS processes. The role requires a commitment to being on the production floor, raising awareness of quality culture, and ensuring the site is inspection-ready.
What You Will Do
The Director will perform trending and reporting for contamination control and environmental data, discuss data with area owners, and build action plans. They will also own the cleaning and disinfection programs, work closely with industry experts, and align with EHS to drive down environmental impact.
Why It Might Be a Fit
The role requires a strong understanding of global regulatory guidance, including CFR 210 and 211, 820, cGXP, ICH Q8, Q9, and Q10, and EU/Eudralex. The Director must have hands-on experience with QMS data management software, process mapping tools, risk assessments, and data analysis. Cross-functional leadership and influence are necessary for success in this role.
Requirements
- Minimum of a bachelor degree, with preference for those in life sciences, engineering, or other science disciplines
- Approximately 12+ years' experience in a similar organization with at least five of those years in a management role
- Advanced knowledge of global regulatory guidance, including CFR 210 and 211, 820, cGXP, ICH Q8, Q9, and Q10, and EU/Eudralex
- Hands-on experience with QMS data management software, process mapping tools, risk assessments, and data analysis
- Cross-functional leadership and influence
]]>