Associate Director / Auditor, Quality Compliance and Audits
Gilead Sciences
5 months ago
On-site
United States
Operations
Associate Director / Auditor (Quality Compliance and Audits - QCA)
Key Responsibilities
- Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, supporting clinical and commercial oral, parenteral, biologic drug products, and associated combination products and medical devices.
- Manage the end-to-end audit lifecycle: audit planning/scheduling, agenda development, audit execution, audit report preparation/issuance, and assessment of responses and adequacy of proposed CAPAs.
- Develop and execute risk-based audit strategies and agendas with appropriate scope, depth, and focus; incorporate internal/external subject matter experts as needed.
- Partner cross-functionally with stakeholders to obtain background information, risk assessments, and business context in advance of vendor audits.
- Contribute to development, implementation, and continuous improvement of audit procedures, tools, templates, and training materials.
- Identify compliance gaps/quality risks/systemic issues and escalate significant/complex findings to management for timely evaluation, prioritization, and resolution.
- Ensure consistency/clarity/quality in audit observation writing, classification, risk assessment, and status tracking.
- Perform due diligence assessments and supplier qualification activities to support business expansion, onboarding of new suppliers, and adoption of new technologies/capabilities.
- Support audit program metrics, continuous improvement initiatives, and performance goals while meeting timelines/deliverables.
- 50% travel required.
Basic Qualifications
- Bachelor’s degree and 10 years of experience; OR Master’s degree and 8 years of experience; OR PhD/PharmD and 5 years of experience.
Preferred Qualifications / Skills
- Bachelor’s (BS/BA) with 10+ years of relevant GMP/GDP audit experience in pharma/biotech; or Master’s (MS) with 8+ years; or equivalent combination.
- Demonstrated biotech and/or pharma industry experience.
- Proven GMP/GDP auditor with experience conducting independent audits and contributing to/leading cross-functional and team-based audits.
- In-depth knowledge of GMP/GDP principles and global regulatory requirements (e.g., 21 CFR Parts 210/211, EU EudraLex Volume 4; ICH, ISO, PIC/S; USP/EP).
- Understanding of manufacturing/testing/distribution across modalities and dosage forms (e.g., APIs, oral solids, liquids, biologics, aseptic fill/finish, packaging, warehousing/distribution).
- Strong risk-based auditing methodology and full audit lifecycle knowledge (planning, execution, reporting, follow-up).
- Ability to interpret and apply evolving regulatory expectations and quality standards.
- Excellent written, verbal, and interpersonal communication; ability to communicate across technical, operational, and executive audiences.
- Strong organizational/leadership/time-management skills; ability to work independently, manage competing priorities, and exercise sound judgment.
People Leader Accountabilities (if applicable)
- Create Inclusion
- Develop Talent
- Empower Teams
Benefits (as stated)
- May be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities
- Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, supporting clinical and commercial oral, parenteral, biologic drug products, and associated combination products and medical devices.
- Manage the end-to-end audit lifecycle: audit planning/scheduling, agenda development, audit execution, audit report preparation/issuance, and assessment of responses and adequacy of proposed CAPAs.
- Develop and execute risk-based audit strategies and agendas with appropriate scope, depth, and focus; incorporate internal/external subject matter experts as needed.
- Partner cross-functionally with stakeholders to obtain background information, risk assessments, and business context in advance of vendor audits.
- Contribute to development, implementation, and continuous improvement of audit procedures, tools, templates, and training materials.
- Identify compliance gaps/quality risks/systemic issues and escalate significant/complex findings to management for timely evaluation, prioritization, and resolution.
- Ensure consistency/clarity/quality in audit observation writing, classification, risk assessment, and status tracking.
- Perform due diligence assessments and supplier qualification activities to support business expansion, onboarding of new suppliers, and adoption of new technologies/capabilities.
- Support audit program metrics, continuous improvement initiatives, and performance goals while meeting timelines/deliverables.
- 50% travel required.
Basic Qualifications
- Bachelor’s degree and 10 years of experience; OR Master’s degree and 8 years of experience; OR PhD/PharmD and 5 years of experience.
Preferred Qualifications / Skills
- Bachelor’s (BS/BA) with 10+ years of relevant GMP/GDP audit experience in pharma/biotech; or Master’s (MS) with 8+ years; or equivalent combination.
- Demonstrated biotech and/or pharma industry experience.
- Proven GMP/GDP auditor with experience conducting independent audits and contributing to/leading cross-functional and team-based audits.
- In-depth knowledge of GMP/GDP principles and global regulatory requirements (e.g., 21 CFR Parts 210/211, EU EudraLex Volume 4; ICH, ISO, PIC/S; USP/EP).
- Understanding of manufacturing/testing/distribution across modalities and dosage forms (e.g., APIs, oral solids, liquids, biologics, aseptic fill/finish, packaging, warehousing/distribution).
- Strong risk-based auditing methodology and full audit lifecycle knowledge (planning, execution, reporting, follow-up).
- Ability to interpret and apply evolving regulatory expectations and quality standards.
- Excellent written, verbal, and interpersonal communication; ability to communicate across technical, operational, and executive audiences.
- Strong organizational/leadership/time-management skills; ability to work independently, manage competing priorities, and exercise sound judgment.
People Leader Accountabilities (if applicable)
- Create Inclusion
- Develop Talent
- Empower Teams
Benefits (as stated)
- May be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.