Insight Global Keyword Location Search view all jobs Sr. GxP Systems Quality & Compliance Consultant Malvern, PA Posted 2 days ago Apply Now 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. Skills and Requirements
• 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.
• 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com. Apply Now Active Filters Sr. GxP Systems Qualit... Malvern, PA Clear All Powered By Cookie Policy We use cookies to improve your experience on our site. To find out more, read our privacy policy Accept Cookies Decline Cookies