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
Key Responsibilities & Activities:
• Support implementation of Quality Strategy for Gilead Mexico and business strategies regarding product distribution, testing and release to the market.
• Support and conduct Quality Management System for the affiliate to comply with COFEPRIS requirements in NOM-059-SSA1; this includes but is not limited to SOPs covering all local activities, samples management, return of goods, product complaints and counterfeit, recall processes, quality risk assessments, change management, etc.
• Provides QA oversight to the GxP contracted organization in Mexico like Third Party Logistic Partners (3PLs) for warehousing & distribution, and Contracted Testing Laboratories (CTL) to address standard documentation and ensure GMP, GDP and GLP compliance for site readiness for inspection.
• Ensure efficient and effective QA support for product warehouse, transportation, testing and disposition of finished products.
• Responsible for documental evaluation in support to Drug Products release to the Mexican market in compliance with the global quality standards and local regulations
• Support opportunely Method Transfer activities required to ensure timely testing for first and subsequent lots to be marketed in Mexico.
• Responsible for generation & maintenance of procedures and controlled documents, (e.g. Quality Manual, SOPs, WRK, methods, etc,) ensuring alignment to global standards & applicable global procedures.
• Manage Quality Systems indicators: CAPA, Change Control, Internal and External Deviations, Complaints. Identify and escalate compliance gaps across quality systems.
• Investigate, communicate, and coordinate closure of any deviations to the quality standards, support and/or manage local investigations, ensure proper corrective and preventive actions (CAPAs) are implemented and effective.
• Support and/or manage local Change Control processes to ensure impact assessment is performed, and tasks are implemented.
• Support internal and external training initiatives in line with Gilead training strategies.
• Participate in the Annual Product Review Global Reports ensuring data related to local distribution of Gilead´s products in included, as well in writing local complementary Annual Reports for marketed products in Mexico.
• Support the Quality Management Review (QMR) process, ensuring compliance with regulatory requirements applicable and opportunely communication of site metrics to senior management. 2
• Coordinate Import Permits with 3PL ensuring licenses are available for Drug Product, Reference Standards and Samples importation.
• Support Quality Agreements preparations and keep them updated with each partner performing the outsourced services.
• Keep the data oversite at the site level assuring full compliance with data integrity principles.
• Develop and maintain an effective working relationship with all team members and external stakeholders.
• Collaborate with cross-functional representatives to ensure timely implementation of quality records.
• Support Method Transfer and actions required for New Product Launches.
• Support internal site audits and Health Authority inspections ensuring adherence to audit schedule and timely closure of findings.
• Participate and support external audits/inspections processes to local service providers.
• Observes and enforces the Corporate Ethical Business Practices
• Additional duties as assigned.
Experience and Skills:
• Demonstrate proficiency in GMP/GDP/Good Laboratory Practices (GLPs) principles, concepts, and best practices in the Mexican and international environment.
• Demonstrate proficiency in application of QA principal concepts, industry practices and standards.
• Demonstrate strong understanding of the applicable regulation on the Mexican market for pharmaceutical imported products warehousing / distribution / testing requirements. Experienced in drug product release process and the interface with other functions like manufacturing, distribution, validation and maintenance.
• Demonstrates ability to effectively manage multiple projects/priorities
• Demonstrates strong verbal, technical writing and report writing skills.
• Demonstrate experience and ability to work in partnership with multidisciplinary and multicultural groups. Hands on attitude.
• Experience in the quality management of outsourced operations (i.e. contract testing/ warehousing and distribution organizations).
• Superb attention to detail, excellent review skills and ability to organize and manage multiple tasks in a fast-paced environment.
• Teamwork oriented.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications
• Demonstrates knowledge of Six Sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
Experience:
• Over 5 years of relevant experience in Pharmaceutical technical operations in quality related roles.
• Holds a Pharmaceutical degree or equivalent dully registered.
• Previous experience in quality assurance aspects for imported products to the Mexican market is required.
• Experience as GMP auditor is desired.
• Previous QC analytical role is desired.
• Excellent English skills
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Top Skills
What We Do
The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases.
Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world.
For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong.
At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”
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