Director, QA Validation & Computer Systems Assurance

Director of QA Validation (QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance) for a biopharmaceutical manufacturing site in Saratoga Springs, NY (also Rensselaer, NY). Monday–Friday, 8am–4:30pm.

Responsibilities:
- Own/maintain the Site Validation Master Plan (VMP) for process, cleaning, sterilization, utilities, and equipment qualification.
- Design and implement risk-based qualification/requalification programs per FDA/EMA/ICH guidance.
- Ensure validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) meets regulatory expectations.
- Lead periodic review programs to maintain validated state for equipment, utilities, and automated systems.
- Lead the CSA program (FDA 2022 guidance, GAMP 5 2nd ed.); evolve from prescriptive CSV to risk-based assurance.
- Own the site SDLC framework for GxP software/computerized systems (MES, DCS/SCADA, LIMS, EBR/ERP integrations, data historians).
- Establish testing strategies (scripted/unscripted) based on software category, intended use, and risk.
- Oversee supplier/vendor assessments for GxP software.
- Ensure data integrity by design (audit trails, access controls, 21 CFR Part 11/EU Annex 11).
- Partner with IT/automation/manufacturing engineering to integrate CSA into procurement, development, and change management.
- Provide QA oversight for qualification of automated systems (continuous manufacturing, PAT, automated material handling).
- Review/approve GxP documents (protocols/reports, CSA plans/assessments, change controls, deviations/investigations, risk assessments, SOPs, VMP).
- Provide QA validation/CSA oversight in change control; scope impact assessments and requalification/revalidation.
- Present/defend validation and CSA programs during FDA/EMA/other inspections; lead inspection-ready documentation and readiness.
- Monitor evolving regulatory guidance relevant to validation/CSA/data integrity.
- Lead and manage validation/CSA team; develop/manage budgets, contractor resources, schedules, and staffing.

Qualifications/Skills:
- BS/BA required (Engineering, Computer Science, Life Sciences, or related); advanced degree preferred.
- 12+ years in pharma/biopharma manufacturing; 7+ years in validation, CSA, or QA.
- 5+ years people management in a GxP environment.
- Direct experience leading computer systems assurance or CSV for commercial biologics/pharma sites.
- Working knowledge: SDLC (GAMP 5 2nd ed.), FDA CSA guidance (2022), 21 CFR Part 11, EU Annex 11, ICH Q9(R1)/Q10.
- Experience with MES, DCS/SCADA, LIMS, ERP/EBR in GMP context.
- Preferred: experience representing validation/CSA in regulatory inspections (FDA PAI/BPAI or EMA).
- Strong risk management knowledge.

Application: Apply now.