Manager, Manufacturing

Gilead Manufacturing Risk Assessment Leader

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

Responsible for ownership, execution, and governance of Manufacturing risk assessments and change controls. This role provides leadership to ensure risk-based decision making, compliant execution of changes, and timely support of manufacturing operations while maintaining alignment with cGMP and regulatory expectations. The position collaborates closely with cross-functional partners and stakeholders to ensure risks are properly identified, assessed, mitigated, and documented, and manufacturing changes are effectively implemented without compromising product quality or supply.

RESPONSIBILITIES:

• Plans, executes, and tracks Manufacturing risk assessments and manufacturing-driven change controls in coordination with cross-functional departments, internally or externally.
• Provides focused ownership for Manufacturing risk assessment activities, including creation, updates, and periodic reviews, in alignment with approved methodologies and site procedures.
• Exercises judgment within generally well-defined procedures and practices to determine appropriate actions related to risk-based decisions and manufacturing changes.
• Normally receives no instruction on routine work and general instructions on new assignments.
• Oversees and contributes to the completion of technical and operational activities related to Manufacturing risk assessments and change controls through effective planning and prioritization.
• Manages complex processes across functions and interacts effectively with stakeholders to ensure regulatory requirements are met.
• Responsible for initiating and directing the implementation of Manufacturing changes across multiple projects and production areas, including coordination of impact assessments and approvals.
• Tracks risk assessment and change control activities against established timelines and adjusts priorities based on changing Manufacturing and business needs.
• Directs issue resolution and supports cross-functional alignment throughout the lifecycle of risk assessments and change controls.
• Supports development and maintenance of training materials related to Manufacturing risk assessments and change controls.
• Creates, supports, or reports performance metrics related to risk assessment and change control execution and contributes to continuous improvement.

Knowledge & Skills

• Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of applicable regulatory requirements and guidance documents.
• Demonstrates understanding of risk-based approaches within a Manufacturing environment.
• Is able to provide solutions to moderately complex to semi-routine problems.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates strong computer, organizational, and project management skills.
• Demonstrates ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.

Education & Experience

• 7+ years of relevant experience with a BS or BA preferred.
• 5+ years of relevant experience with an MS preferred.
• Prior experience in a cGMP-related industry is required; biopharmaceutical or pharmaceutical manufacturing experience preferred.

The salary range for this position is: $123,930.00 - $160,380.00. 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:

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

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact View email address on click.appcast.io for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

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