Quality Assurance Manager

Gilead Sciences Mexico, S. de R.L. de C.V.; Ciudad de México; Presencial; MXN 800,000 - 1,000,000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Ciudad de México is seeking a Quality Assurance professional to oversee compliance with regulatory standards. The ideal candidate will have over 7 years of experience in quality management, deep understanding of GMP regulations, and excellent communication skills. Responsibilities include acting as a liaison with health authorities, managing quality systems, and ensuring compliance with local and international standards. This position plays a crucial role in maintaining the company's commitment to quality and integrity in the pharmaceutical industry.

Formación

• Experience in quality management of outsourced operations.
• Demonstrated ability to manage multiple projects/priorities.
• Excellent verbal, written and interpersonal communication skills.

Responsabilidades

• Act as the Sanitary Responsible Deputy Person for Gilead Sciences Mexico.
• Serve as QA subject matter expert in external audits.
• Manage Quality Systems indicators and ensure compliance.
• Develop and maintain relationships with stakeholders.
• Coordinate internal and external training initiatives.
• Support and manage local Change Control processes.

Conocimientos

GMP/GDP principles

Mexican Sanitary regulations

Regulatory communication

Project management

Attention to detail

Microsoft Office proficiency

Educación

Pharmaceutical degree or equivalent

Descripción del empleo

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 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 and 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 maintain 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 and 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 duly 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.