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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. Extensive experience in 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.
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.