Senior Qualified Person

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

Senior Qualified Person

Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use. 5+ years of QP Release of Finished goods to Market, including experience in Secondary Packaging operations. This role is an onsite role 5 days a week.

Role

QP review and release of Finished Goods to market.

Primary QP team representative on the daily Finished Goods Operations Board and supporting meetings.

Collaborates closely with the Planning and Packaging functions to schedule and coordinate the workload of the QPs performing release of Secondary Packaged Finished product to the market.

Facilitate QP team achieving site Finished Goods release metrics.

Serves as a project lead within Finished Good release team.

Primary QP contact for investigations impacting Packaging operations at the site

Determines corrective action on investigative findings and with consideration of the long-term impact of decisions.

Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors, considerable judgment is required in resolving problems and making routine recommendations.

Exercises judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.

Extensive knowledge of FDA / EMEA and other global regulatory compliance guidelines for drug manufacturing, packaging, and distribution.

Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.

Serves as a point of contact with internal stakeholders and external customers, providing necessary information and troubleshooting to ensure resolution of issues.

Demonstrates ability in managing competing priorities creating an effective team environment.

Demonstrates ability to be an influencer without authority.

Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.

Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.

Demonstrates excellent verbal, written, and interpersonal communication skills.

Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.

Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.

Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.

Knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.

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 careers@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 jobs in France:

Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com