Senior Manager, Quality Assurance

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

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job Description

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.As aSenior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality organization. This position is dedicated to managing and supporting the Gilead Global Quality Agreement Program.

This position will have high visibility throughout the PDM organization as the Global Process Owner (GPO) for Gilead's Global Quality Agreement Program and will collaborate with key internal partners & stakeholders to establish and maintain an effective Global Quality Agreement Program. This position will serve as the primary subject matter expert (SME) for matters related to Quality Agreement content, Quality Agreement lifecycle management, Quality Agreement negotiations, management of Quality Agreement templates in compliance with applicable laws and regulatory requirements, and supporting continuous improvement initiatives related to the Global Quality Agreement Program.

Job Responsibilities

• Serves as the Global Process Owner (GPO) for Gilead's Global Quality Agreement Program, ensuring the program is compliant, consistent, and effectively implemented across the organization

• Develops, maintains, and continuously improves standardized Quality Agreement templates, guidance documents, training materials, and related tools to align with global regulatory requirements and internal policies

• Serves as the primary subject matter expert (SME) for Quality Agreement content, interpretation, and applicability across internal teams and external partners, which may include supporting internal stakeholders during review, negotiation, implementation, enforcement, and periodic review of Quality Agreements.

• Drives alignment and resolution of complex Quality Agreement terms through collaboration with Legal, Sourcing, and External Quality stakeholders

• Establishes and maintains governance processes, metrics, and reporting for the Global Quality Agreement Program to ensure transparency and effectiveness

• Monitors regulatory trends and evolving expectations related to Quality Agreements and proactively updates program requirements and templates accordingly

• Provides expert support during inspections and audits related to Quality Agreements, including preparation, defense, and remediation activities

• Leads or contributes to continuous improvement initiatives to enhance Quality Agreement processes, reduce cycle times, and improve compliance and user experience

• Supports training and knowledge-sharing activities to ensure consistent understanding and application of Quality Agreement requirements across the organization

The best candidate...

• Demonstrates expertise in Quality Agreements, including development, negotiation, lifecycle management, and governance in a global GMP environment

• Demonstrates strong working knowledge of global regulatory requirements applicable to Quality Agreements (e.g., FDA, EMA, ICH) and ability to translate requirements into compliant contract content

• Demonstrates strong technical writing skills with the ability to draft, review, and standardize Quality Agreement templates and supporting documentation

• Demonstrates advanced stakeholder management, influencing, and negotiation skills across cross-functional and external partner environments

• Demonstrates ability to manage and support complex, high-visibility programs with multiple concurrent deliverables and competing priorities

• Demonstrates strong communication skills, including the ability to clearly articulate Quality Agreement expectations to internal stakeholders and external partners

• Demonstrates the ability to learn quickly and operate effectively in a fast-paced, highly regulated environment

Requirements

• 8+ years of relevant experience in a GMP environment related field and a BS or BA OR

• 6+ years of relevant experience in a GMP environment related field and a MA/MS OR

• 2+ years of relevant experience in a GMP environment related field and a PhD/PharmD

Preferred Knowledge

• Experience working with and managing relationships with Contract Manufacturing Organizations (CMOs) and other external partners is preferred

• Experience interacting with regulatory authorities and supporting inspections related to Quality Agreements or external quality oversight is beneficial and preferred

• Experience managing global programs or serving as a Global Process Owner (GPO) is beneficial

• Familiarity with digital tools or systems supporting document management, contract lifecycle management, or Quality Agreement tracking is beneficial

• Experience and working knowledge with digital Quality Management Systems and Quality Document Management Systems, particularly Veeva Vault, is beneficial..

People Leader Accountabilities

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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