Sr. QA Director
Reporting to the Global Senior VP, oversees all QA functions including Incoming, QA operations Product Release, Documentation Services, CAPA, Complaints, Laboratory Services, Sterilization Validation and Monitoring (EO and Gamma), Customer and Internal Audits for three businesses (Medical, Biopharm / Industrial and SUS). Direct Reports are three (3) Managers, a Senior Product Manager responsible for the Biopharm / Industrial and SUS businesses, a Product Manager for the Medical business and a Quality Systems Manager for the site. QA business unit includes 47 employees including exempt and indirect personnel with an expense budget of approximately $1.3M.
- Responsible for oversight of all product transfers and validation adequacy. Liaison with R&D to achieve product transfer goals and timelines. Reviews and approves Validation Master plans and protocols.
- Participation in preparation of global processes for all Pall sites.
- Establishes challenging goals and metrics for the Quality Department aligned with Corporate. Interacts with corporate headquarters to generate procedures and align all sites ensuring process consistency.
- Currently involved in high priority projects such as new product transfers in Biopharm business, implementing unified Quality system across all businesses, procedure consolidation project, SPC implementation project, simplified CAPA system, contamination control in manufacturing areas, implementation of Lean Initiatives among others.
- Conduct Corporate and Sterilization process audits as required.
- Management Representative for the Quality System and coordination of official regulatory inspections.