Required Skills & Experience
-8+ years of pharmaceutical GxP/CSV experience preferred, with depth of relevant hands-on experience prioritized over a strict years requirement. -Strong hands-on GxP Computer System Validation (CSV) and computerized systems compliance experience within the pharmaceutical industry. -Demonstrated experience independently performing system health checks, compliance gap assessments, periodic reviews, or audits of GxP computerized systems. -Strong knowledge of data integrity, electronic records/e-signatures, risk-based validation, and computerized system lifecycle controls. -Ability to critically evaluate validation and lifecycle evidence, identify compliance risks, and develop pragmatic, risk-based recommendations. -Strong stakeholder communication skills with the ability to constructively challenge current practices and clearly communicate complex findings. Bachelor’s degree in Life Sciences, Engineering, Information Technology, Quality, or a related field, or equivalent relevant experience.
Nice to Have Skills & Experience
-Experience assessing laboratory and manufacturing systems, including ELN, CDS, MES, data platforms, or similar regulated systems. -Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ALCOA+ principles. -Previous experience supporting regulatory inspections or quality audits. -Experience working with global, cross-functional teams.
Job Description
Our large pharmaceutical client in Malvern, PA is seeking a Sr. GxP Systems Quality & Compliance Consultant to conduct independent, risk-based compliance assessments of GxP computerized systems to evaluate their current-state health, identify compliance risks, and recommend prioritized remediation or improvement opportunities.
Primary responsibilities:
-Review system documentation, validation evidence, controls, and lifecycle processes to determine whether systems remain compliant and in a validated state. -Assess areas including GxP classification, validation strategy, requirements and traceability, testing, change control, access controls, electronic records/e-signatures, data integrity, periodic reviews, supplier controls, and operational lifecycle controls. -Interview system owners and stakeholders to understand system use, processes, and controls. -Identify and prioritize compliance gaps and distinguish documentation deficiencies from substantive control weaknesses. -Develop concise, risk-based assessments and actionable recommendations for system owners and senior stakeholders.