Global Quality Agreement Program Lead

Gilead Sciences Inc.; Maryland; On-site; USD 158,000 - 204,000; Full time

Job summary

Gilead Sciences Inc. is seeking a Senior Manager, Quality Assurance to lead the Global Quality Agreement Program. You will act as SME for quality agreements, govern templates, and support negotiations across internal and external stakeholders.

You will interact with Regulatory bodies and drive continual improvements while ensuring compliance with FDA/EMA and ICH requirements in a fast-paced, highly regulated environment.

Qualifications

• 8+ years GMP experience in related field.
• 6+ years GMP experience with MA/MS or equivalent.
• 2+ years GMP experience with PhD/PharmD.
• Experience with CMOs and external partners is preferred.
• Regulatory authorities interactions and inspections experience is beneficial.
• Experience managing global programs or serving as Global Process Owner is beneficial.
• Familiarity with digital QMS and document management systems is beneficial.
• Experience with digital tools for quality document management is helpful.

Responsibilities

• Serve as Global Process Owner for Gilead's Global Quality Agreement Program across the organization.
• Develop and maintain standardized Quality Agreement templates and guidance documents.
• Act as SME for Quality Agreement content, interpretation, and applicability.
• Collaborate with Legal, Sourcing, and External Quality stakeholders for term alignment.
• Establish governance, metrics, and reporting for program transparency.
• Monitor regulatory trends and update requirements and templates accordingly.
• Provide expert support during inspections and audits of Quality Agreements.
• Lead continuous improvement to reduce cycle times and improve compliance.
• Support training and knowledge-sharing on Quality Agreement requirements across the organization.

Skills

Quality agreements

GMP experience

Regulatory knowledge

Technical writing

Stakeholder management

Negotiation

Program governance

Global program management

Contract lifecycle

Veeva Vault

Education

BS/BA in related field

MA/MS in related field

PhD/PharmD

Tools

Veeva Vault

Job description

Gilead Sciences Inc. is seeking a Senior Manager, Quality Assurance to lead the Global Quality Agreement Program. You will act as SME for quality agreements, govern templates, and support negotiations across internal and external stakeholders.

You will interact with Regulatory bodies and drive continual improvements while ensuring compliance with FDA/EMA and ICH requirements in a fast-paced, highly regulated environment.