Associate Director / Auditor, Quality Compliance and Audits
Gilead Sciences
19 days ago
Remote friendly (United States)
United States
Operations
Key Responsibilities:
- Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners (contract manufacturers, laboratories, suppliers, distributors, and other third parties).
- Manage the end-to-end audit lifecycle (planning/scheduling, agenda, execution, report issuance, CAPA adequacy assessment).
- Develop and execute risk-based audit strategies and agendas using internal/external subject matter experts as appropriate.
- Partner cross-functionally to obtain background information, risk assessments, and business context in advance of vendor audits.
- Contribute to audit program continuous improvement (procedures, tools, templates, training).
- Identify compliance gaps/quality risks/systemic issues and escalate significant/complex findings to management.
- Ensure quality of audit observations, classification, risk assessment, and status tracking.
- Perform due diligence and supplier qualification activities as assigned.
- Support audit program metrics and performance goals; meet timelines/deliverables.
- 50% travel required.
Basic Qualifications:
- Bachelor’s degree + 10 years’ experience
OR
- Master’s degree + 8 years’ experience
OR
- PhD/PharmD + 5 years’ experience
Preferred Qualifications / Required Skills:
- 10+ years (BS/BA) or 8+ years (MS) GMP/GDP audit experience in pharma/biotech; or equivalent.
- Demonstrated biotech/pharma industry experience.
- Proven GMP/GDP auditor; experience with independent and cross-functional/team audits.
- In-depth GMP/GDP and global regulatory knowledge (e.g., 21 CFR 210/211, EU EudraLex Vol 4; ICH/ISO/PIC/S; USP/EP).
- Knowledge of manufacturing/testing/distribution across modalities and dosage forms.
- Risk-based auditing and full audit lifecycle skills.
- Strong written, verbal, interpersonal, organizational, leadership, and time-management skills.
Application Instructions (United States):
- Please apply via the Internal Career Opportunities portal in Workday (current Gilead employees and contractors).
- Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners (contract manufacturers, laboratories, suppliers, distributors, and other third parties).
- Manage the end-to-end audit lifecycle (planning/scheduling, agenda, execution, report issuance, CAPA adequacy assessment).
- Develop and execute risk-based audit strategies and agendas using internal/external subject matter experts as appropriate.
- Partner cross-functionally to obtain background information, risk assessments, and business context in advance of vendor audits.
- Contribute to audit program continuous improvement (procedures, tools, templates, training).
- Identify compliance gaps/quality risks/systemic issues and escalate significant/complex findings to management.
- Ensure quality of audit observations, classification, risk assessment, and status tracking.
- Perform due diligence and supplier qualification activities as assigned.
- Support audit program metrics and performance goals; meet timelines/deliverables.
- 50% travel required.
Basic Qualifications:
- Bachelor’s degree + 10 years’ experience
OR
- Master’s degree + 8 years’ experience
OR
- PhD/PharmD + 5 years’ experience
Preferred Qualifications / Required Skills:
- 10+ years (BS/BA) or 8+ years (MS) GMP/GDP audit experience in pharma/biotech; or equivalent.
- Demonstrated biotech/pharma industry experience.
- Proven GMP/GDP auditor; experience with independent and cross-functional/team audits.
- In-depth GMP/GDP and global regulatory knowledge (e.g., 21 CFR 210/211, EU EudraLex Vol 4; ICH/ISO/PIC/S; USP/EP).
- Knowledge of manufacturing/testing/distribution across modalities and dosage forms.
- Risk-based auditing and full audit lifecycle skills.
- Strong written, verbal, interpersonal, organizational, leadership, and time-management skills.
Application Instructions (United States):
- Please apply via the Internal Career Opportunities portal in Workday (current Gilead employees and contractors).