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.
Health insuranceDental insuranceVision insuranceEquity / stock optionsPerformance bonus
Additional Information
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.
Gilead Sciences · - California - LA Verne