• Ensure Vertex Mexico is compliant with local operation and licenses maintenance for pharmaceutical activities in the framework of Mexico Regulations and Guidelines
• In cooperation with International QA teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS).
• Civil and criminally liable for the actions and products of Vertex in Mexico
• Vertex full representation before Mexican Health Authority (COFEPRIS) and contact person with COFEPRIS, note regulatory support will be outsourced.
• Serve as local QP/RP quality representative to ensure QMS and licences accurately reflect current operations and update as necessary ensuring Sanitary Compliance/ notification of operation.
• Responsible for the product release in Mexico as RP, all local documentary Co A, etc.
• Establish and maintain QMS, ensuring documented system is in place to support Gx P compliance management both internally and externally, with third parties to whom activities are delegated.
• Maintain oversight of outsourced activities, including for regulatory support and associated quality technical agreements in Mexico & Central America.
• Support product recall and mock recall operations for Vertex local sites.
• Act as the ‘go-to’ LLR & QA Subject Matter Expert.
• Maintain QA oversight of Named Patient Supply and Managed Access programs.
• Ensure QA oversight in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
• Maintain effective relationships with distribution QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight in Mexico & Central America.
• Build effective relationships with supply chain in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
• Assess the impact and approve deviations, CAPAs and Change Control related to QMS.
• In collaboration with supply chain, ensure that supply chain maps are maintained for all distribution channels.
• Manage internal audits and support external audit scheduling, scope and other qualification activities. And support Inspection preparation and management, prior to, during and following any Competent Authority inspection of local and regional locations.
• Support Vendor Audits for new and existing vendors; ensure reports are prepared in a timely manner and responses adequately address observations.
• Identify risks/communicate gaps to quality system owners/QLTs; ensure affiliate proactive risk assessments are maintained and risks identified are communicated appropriately.
• Act as escalation lead for quality issues meeting escalation criteria.
• Serve as Reviewer/Approver or Owner of deviations to processes
• Monitor and trend events related to processes and identify/propose Corrective Actions to address/May serve as CAPA Owner
• Act as Responsible Person for Mexico Affiliate as required. Performs the duties of Responsible Person (RP) with the requirements of current Good Distribution practices and Vertex Procedures. The following activities are undertaken as RP and the RP has authority to take decisions with regards to these responsibilities:
• Ensure that the QMS in Vertex site is implemented and maintained, including the management of authorised activities and quality of records.
• Ensure that initial and continuous training programs are implemented and maintained for Vertex staff involved in the Wholesale dealing operations.
• Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
• Ensure that customers and suppliers are approved
• Approving any subcontracting that may impact GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Keep appropriate records of delegated duties
• Manage the local and regional Management Review process and input into the GMP/GDP Management reviews and assess the risk of inputs such as metrics and identified risks and gaps; Recommend mitigation approaches.
• Participate in Geographic Expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g., Method Transfers for local labs as required for In-Country Test.

• Ability to recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility
• Develop and apply creative solutions that meet demands of the function
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
• Work cross-functionally with all levels to foster exceptional collaboration.
• Root Cause Analysis tools/methodology
• Sense of urgency- ability to act quickly/escalation process/transparency
• Attention to detail
• In- depth knowledge of both the conceptual and practical application of c GMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing
• Strong leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• In-depth experience leading complex projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
• Ability to independently lead cross-functional teams and represent the Quality unit
• Ability to mentor and guide, skilled at transferring technical knowledge and teaching quality management skills
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience and advanced judgement and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions
• Fluency in verbal and written English/Spanish
• Strong experience with electronic document management systems (e.g., Trackwise, Veeva)

• Degree in Pharmacy with experience releasing and supporting local Legal representative responsibilities
• Ability to support regulatory inspections and interact directly with health authorities.
• Strong experience in pharmaceutical sector

Hybrid-Eligible Or On-Site Eligible