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Quality Assurance Associate Director

メキシコ - メキシコシティ品質保証正社員

仕事内容

Essential Duties & Job Functions:

The responsibilities for this role include, but are not limited to:

  • Act as the Sanitary Responsible in front of the Health Authorities for the office location and as per Business strategy.

  • Oversee the development and implementation of Quality Strategy for Gilead Mexico.

  • Part of the leadership affiliate team to support the affiliate strategies for product launchings.

  • Provide leadership and operational excellence to enable the Quality function to work effectively in a commercial environment, support business strategies regarding, product distribution, testing and release.

  • Collaborate cross-functionally and geographically with stakeholders to ensure that product distribution processes are aligned to the needs of Gilead and its customers, ensuring best practices, compliance and alignment with business needs.

  • Monitor and ensure compliance with new GMP and GDP regulations. Establish and publish Key Performance Indicators to track GMP and GDP compliance across the operation.

  • Interface with regulatory agencies as required, representing Gilead and participates in regulatory authority inspections.

  • Develop and effective working relationship with all team members and external stakeholders.

  • Lead/coordinate investigations define and implement corrective and preventive actions (CAPAs) related to in country operations.

  • Coordinate the appropriate resources allocation for affiliate specific projects.

 Specific Responsibilities:

  • Prepares and maintains updated Quality Agreements with each partner performing the outsourced services in coordination with the Global Quality group.

  • Provides QA oversight to the GXP contracted organization in Mexico (i.e. Warehousing / distribution and testing laboratories).

  • Responsible for product 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 to the senior management

  • Participates and keeps records of all methodology transfers needed for approved Marketing Authorization(s) - MA(s) 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.

  • Host and coordinate Gilead internal affiliate audit.

  • Establish a 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.

  • Foster the quality culture acting as a Quality ambassador and role model.

  • Prepare and coordinate timely submissions of Annual Reports for marketed products.

  • Lead continuous improvement efforts in quality systems and department infrastructure through the evaluation of trends in key performance indicators, audit outcomes and corrective and preventive actions.

  • Represent QA in the affiliate leadership team boards.

  • Ensures the evaluation, trending and communication of quality data for management review.

  • Coordinate the local Quality Management Review board, presenting the relevant data and coordinating actions.

  • Provide cGMP guidance and inputs to internal departments as applicable.

  • Prepare and submit waivers, reports and technical quality related topics to the Agency and follow up the actions and regulatory commitments.

  • 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.

  • Ensure robust corrective actions are identified and implemented as a response of deviations or site auditing.

  • Support as needed COFEPRIS international inspections of the manufacturing sites.

  • Be updated and communicate new and regulation changes to senior management in a timely manner. Must be prepared to respond diligently to Health authorities inquiries based on accurate technical information.

  • Act as the Subject Matter Expert for the Mexican Market as part of Global technical discussions as required.

  • Observes and enforces the Corporate Ethical Business Practices and other oversee the implementation of any Global quality initiative.

  • Manages site QA budget.

  • Provides QA support for the review and approval of method validation protocols and reports, product specification and change control documentation.

  • Assist in the preparation and review of product regulatory submissions and variations to the local Health authority.

  • Provide relevant information from the local market in preparation for APQR´s and quality assessments as needed.

  • Represent the QA affiliate in regional and global forums.

Competencies / Skills / Knowledge

  • 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.

  • 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.

  • Team work oriented, strategic mindset and leadership skills complete the desired skills for this role.

Education & Experience:

  • Over 10 years of relevant experience in Pharmaceutical technical operations in quality related roles.

  • Holds a Pharmaceutical degree dully registered.

  • Previous experience in quality assurance aspects for imported products to the Mexican market is required.

  • Previous QC analytical role is desired.

  • Excellent English skills.