Associate Director, Quality (Validation and Data Integrity)
On-siteBala Cynwyd, Pennsylvania, United States
Job Summary
Provide Quality oversight of Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for initial implementations, changes, and maintenance of GxP systems. Execute risk assessments and manage planning to ensure computerized systems remain qualified throughout their lifecycles. Review and approve validation documentation including URS, FRS, CS, DS, IOQ, PQ/UAT, VP, VSR, RA, and TM. Streamline GxP compliance processes with IT and business teams while participating in project teams to guide validation documentation and change controls. Manage the data integrity program timeline for deliverables such as assessments and CAPA actions. Deliver training on validation principles and create or review policies and SOPs. Serve as a Subject Matter Expert for vendor audits, internal audits, and GxP health authority inspections.
Required Qualifications
- Bachelor's degree in a scientific or technical discipline
- 8+ years of experience in a Quality role in the biotechnology/pharmaceutical industry
- at least 3 years' direct experience with GxP computer systems validation
- Experience with GxP validation methodology
- Strong understanding of 21 CFR Part 11
- Strong understanding of EU Annex 11 regulations
- Strong understanding of GAMP 5 concepts, applications and best practices
- Must possess strong attention to detail
- ability to work independently and collaboratively in a fast-paced environment
- Demonstrated ability to initiate process improvements
- ability to set priorities
- ability to meet aggressive timelines
- Must be in the office located in Bala Cynwyd, PA
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