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
Knowledge:
Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).
Demonstrates working knowledge of Quality systems and processes.
Demonstrates knowledge of FDA / EMEA standards and guidelines.
Demonstrates basic knowledge of six sigma, LEAN and/or root cause analysis tools used for identifying and correcting deficiencies.
Demonstrates investigation skills and technical writing skills.
Demonstrates effective verbal, written, and interpersonal communication skills.
Demonstrates working proficiency in Microsoft Office applications.
Basic Qualifications:
4+ years of relevant experience in a GMP environment or related field and a BS or MS degree.
OR
5+ years of relevant experience and an AA degree.
OR
Prior experience in pharmaceutical industry.
Specific Job Responsibilities:
Reviews and approves CMO (Contract Manufacturing Organization) master batch records.
Performs review of primary and secondary packaging lot packets.
Performs review/approval of various GMP packaging documents related to CMO operations.
Executes QA review of packaged products intended for further processing or distribution.
Interfaces with CXOs to provide QA oversight of routine manufacturing/packaging activities.
Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Adheres to programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Reviews manufacturing/packaging control data for in process and finished products with guidance from senior colleagues.
Authors applicable sections of annual product reviews related to manufacturing/packaging of product and reviews applicable CMO annual product review reports.
Supports CXO investigations and may lead Gilead investigations to ensure robust root cause assessment and identification of corrective and preventive action (CAPA).
Works with cross-functional teams during new product start-ups and product launch, with guidance from senior QA colleagues.
Normally receives no instruction on routine work, general instructions on new assignments
People Leader Accountabilities:
Create Inclusion - knowing the 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 employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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:
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 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 apply via the Internal Career Opportunities portal in Workday.