Supports, facilitates, and adapts the Gilead Quality Management System for equipment, utilities, facilities, processes, and/or automation systems to ensure that it meets regulatory and industry standards and expectations. Provide quality oversight for commissioning, qualification, and validation activities for Gx. P pilot plants and GMP warehouse equipment, utilities, and automation systems. Work closely with the Business Process Owners, Facilities, Validation, and Engineering teams to ensure th... more details
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
Senior Manager, Quality Systems
Responsibilities:
Supports, facilitates, and adapts the Gilead Quality Management System for equipment, utilities, facilities, processes, and/or automation systems to ensure that it meets regulatory and industry standards and expectations.
Provide quality oversight for commissioning, qualification, and validation activities for GxP pilot plants and GMP warehouse equipment, utilities, and automation systems.
Work closely with the Business Process Owners, Facilities, Validation, and Engineering teams to ensure that GxP systems are deployed according to company standards and relevant regulations and maintained in a validated state.
Reviews and approves validation deliverables for medium-to-large-sized projects.
Provide technical and quality qualification assessment and approval for engineering and process changes.
Review and approve Pilot Plant’s GMP Drawings
Review and approve Asset Induction, Unscheduled work orders, and environmental monitoring records.
Review and approve procedures, work instructions, and other governing documents to support Gilead’s GxP systems.
Provide oversight and QA approvals for GxP Deviations, CAPAs, and change controls to ensure activities comply with Gilead procedures and regulatory requirements.
Provide expert guidance on commissioning and validation activities on equipment, utilities (e.g., HVAC, Nitrogen, Water Systems), and automation systems (Siemens BMS, EBR, GxP PI Historian, Process Control Systems, Temperature Data Mapping System, LabWatch).
Cross-functional collaboration: Collaborate with cross-functional teams, including facilities, engineering, manufacturing, and validation, to align processes and drive continuous improvement initiatives.
Standardization: Develop and implement standardized processes, procedures, guidelines, and best practices to ensure consistency and compliance across all pilot plant operations.
Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).
Interface with regulatory agencies as required.
Performs various activities to ensure compliance with quality systems, quality procedures, and applicable regulatory requirements.
Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
Participate in developing training programs regarding all aspects of quality systems administration.
Participates in compliance audits as required.
Knowledge and Skills:
Demonstrates proficiency in regulatory requirements pertaining to equipment, utilities, facilities, and automation systems commissioning/validation in GxP environments.
Demonstrates proficiency in understanding and applying GMP regulations related to manufacturing, GMP warehouse, test laboratories, and facility operations.
Demonstrates knowledge of qualification engineering principles and concepts applicable to process, system performance, and regulatory requirements.
Demonstrate a strong technical and analytical understanding of Biologics Manufacturing.
Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.
Demonstrate knowledge of shipping qualification.
Demonstrate ability to problem solve and lead process improvements.
Demonstrate ability to lead cross-functional meetings and make decisions as a QA representative.
Demonstrates strong verbal, technical writing, and interpersonal skills.
Experience interfacing with regulatory authorities to present company methodologies and deliverables during inspections.
Minimum Qualifications:
The salary range for this position is: $154,020.00 - $199,320.00. 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.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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:
Please log onto your Internal Career Site to apply for this job.
