Quality Assurance Associate Directorメキシコ - メキシコシティ品質保証正社員
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.
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.