Quality Assurance Manager

Essential Duties and Job Functions:

• Act as the Sanitary Responsible Deputy Person in front of the Health Authorities for Gilead Sciences Mexico.
• Serve as QA subject matter expert in external audits.
• Manage business strategies regarding product distribution, testing and release.
• Oversee GMP suppliers and Gilead´s Mexico Warehouse Quality System to ensure GMP and GDP compliance.
• Manage Quality Systems indicators: CAPA, Change Control, Internal and External Deviations, Complaints. Identify and escalate compliance gaps across quality systems.
• Own the Quality Management Review (QMR) process, ensuring compliance with regulatory requirements applicable and opportune communication of site metrics to senior management.
• Support implementation of Quality Strategy for Gilead Mexico.
• Develop and maintain effective working relationships with all team members and external stakeholders.
• 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 proper change an impact assessment is performed, and tasks are implemented.
• Collaborate with cross-functional areas to ensure timely implementation of quality records.
• Responsible for procedures issuance and updates for ensuring alignment to operations.
• Coordinate Import Permits with 3PL ensuring licenses are available for opportunely Drug Product, Reference Standards and Samples importation.
• Support Method Transfer and actions required for New Product Launches.
• Support affiliate specific projects.
• Manage internal site audits ensuring adherence to audit schedule and timely closure of findings.
• Additional duties as assigned.

• Prepare and maintains updated Quality Agreements with each partner performing the outsourced services.
• Provides QA oversight to the GxP contracted organization in Mexico (i.e. warehousing / distribution and testing laboratories).
• Responsible for documental evaluation in support to Drug Products release to the Mexican market in compliance with the global quality standards and local regulations.
• Investigate, communicate, and coordinate closure of any deviations to the quality standards as well as the action plans.
• Escalate quality compliance issues.
• Support opportunely Method Transfer activities required to ensure timely testing for first and subsequent lots to be marketed in Mexico.
• Participate and support the coordination of all GILEAD audits to local service providers.
• Manage Gilead internal affiliate audit.
• Manage the Quality Management System for the affiliate to comply with COFEPRIS requirements in NOM-059-SSA1; this includes but is not limited to SOPs to cover all local activities, samples management, return of goods, product complaints and counterfeit, recall processes, quality risk assessments, change management, etc.
• Keep the affiliate Quality Manual and site-specific master files dully updated.
• Coordinate internal and external training initiatives in line with Gilead training strategies.
• Prepare complementary local Annual Reports for marketed products.
• Contribute to Annual Product Review Global Reports ensuring data related to local distribution of Gilead´s products in included.
• Ensure efficient and effective QA support for product warehouse, transportation, testing and disposition of finished products.
• Develop plans and implement actions to ensure that the site operates in compliance with cGMP, cGDP expectations.
• Keep the data oversite at the site level assuring full compliance with data integrity principles.
• Collaborate with contractors of outsourced activities ensuring site readiness for inspection.
• Observes and enforces the Corporate Ethical Business Practices and other oversee the implementation of any Global quality initiative.

• Demonstrate in- depth understanding and application of GMP/GDP principles, concepts, and best practices in the Mexican and international environment.
• Depth knowledge in Mexican Sanitary regulations
• 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.
• Demonstrates ability to effectively manage multiple projects/priorities
• Capable to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness and where precedent may not exist.
• Excellent verbal, written and interpersonal communication skills.
• Confident to interact with the regulatory agency and able to represent GILEAD in public forums as needed.
• 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
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial