Quality Assurance Manager

Description 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 elevate 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. Specific Responsibilities : 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. Knowledge, Experience and Skills : 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 Experience : Over 7 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. 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. #J-18808-Ljbffr