Quality Senior Manager
hace 4 semanas
Job Description
General Summary:
Senior QA Manager ensuring quality compliance in Mexico local affiliate & Central America. This position holder has an oversight of the distribution network Panama, Costa Rica, Guatemala, Dominican Republic, Peru and Ecuador, including distribution partners from these countries, and will lead quality oversight initiatives associated with local affiliate and the region. This role supports commercial activities related to GDP, GMP and geographic expansion, participates in regulatory inspections covering GDP and GMP (as required). The role also acts as the Local Legal Representative (LLR) & Responsible Person (RP/QP) completed the local release for the Mexico Vertex Affiliate.
Key Duties and Responsibilities:
- 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 CoA, etc.- Establish and maintain QMS, ensuring documented system is in place to support GxP 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 met
-
Senior Quality Manager
hace 1 mes
Ciudad de México, Ciudad de México Eastek International Corporation A tiempo completoJob Title:Senior Quality ManagerJob Summary:Eastek International Corporation is seeking a Senior Quality Manager to lead the implementation of advanced quality strategies and maintain quality standards such as ISO, IATF, and FDA at our global offices and manufacturing facilities.Key Responsibilities:Ensure products and services meet the highest level of...
-
Senior Quality Operations Manager
hace 5 días
Ciudad de México, Ciudad de México General Motors A tiempo completoAbout the Role:As a Senior Quality Operations Manager at General Motors, you will play a crucial part in ensuring vehicle engineering meets quality requirements.Key Responsibilities:Monitor consistency with Global Metric Definitions and PerformanceMaintain documentation of Launch Manufacturing Quality Readiness ReviewsParticipate in Plant Quality Manager...
-
Senior Quality Manager
hace 1 semana
Ciudad de México, Ciudad de México Motorola Solutions A tiempo completoJob OverviewWe are seeking a highly skilled Senior Quality Manager to lead our quality initiatives and ensure seamless integration with our global Supply Chain.
-
Senior Quality Manager
hace 1 mes
Ciudad Apodaca, Nuevo León, México Methode Electronics, Inc. A tiempo completoJoin Methode Electronics, Inc. as a Senior Quality Manager in our North American Automotive Division.About the RoleWe are seeking an experienced Senior Quality Manager to lead our quality team and drive excellence throughout the entire value chain from production to end customer.Key Responsibilities:
-
Senior Quality Manager
hace 2 semanas
Ciudad de México, Ciudad de México Abb A tiempo completoA challenging opportunity awaits an ambitious professional in the quality assurance field. As a Senior Quality Manager at ABB, you will play a crucial role in deploying and maintaining a robust quality culture on site.Key Responsibilities:Lead a team of technicians in ensuring product inspections are coordinated efficiently.Analyze warranty claims to...
-
Senior Quality Assurance Manager
hace 1 mes
Ciudad de México, Ciudad de México Alstom A tiempo completoAbout AlstomAt Alstom, we strive to create innovative solutions for the transportation industry. Our team of over 75,000 professionals is dedicated to making a positive impact on the environment and communities around the world.Job Title: Senior Quality Assurance ManagerEstimated Annual Salary: $95,000 - $125,000About the RoleWe are seeking an experienced...
-
Senior Software Quality Assurance Manager
hace 4 semanas
Ciudad de México, Ciudad de México Sabenza IT A tiempo completoSenior Software Quality Assurance ManagerSabenza IT, Testing, ITAn established global provider of premium and luxury cars and a leading manufacturer of commercial vehicles seeks an experienced Senior Software Quality Assurance Manager to join their dynamic team.Estimated Salary: R1,200,000 - R1,800,000 per annumAbout the Role:The successful candidate will...
-
Senior Quality Engineering Manager
hace 1 mes
Ciudad de México, Ciudad de México Acute Talent A tiempo completoJob OverviewAcute Talent is seeking a highly skilled Senior Quality Engineering Manager to lead our QA efforts and drive quality excellence in software delivery. As a key member of our team, you will be responsible for developing and implementing test strategies that ensure higher quality delivery and test coverage.Key Responsibilities:Collaborate with Agile...
-
Senior Quality Assurance Manager
hace 3 semanas
Ciudad de México, Ciudad de México Lear Corporation A tiempo completoAbout Lear Corporation">Lear, a global Tier 1 automotive supplier, is dedicated to serving all the world's major automotive manufacturers with innovative automotive seating and electrical products. Our diverse team of over 165,000 people operates in 39 countries worldwide.">We are seeking a talented Quality Assurance Manager to join our successful teams and...
-
Senior Quality Manager
hace 2 semanas
Santiago de Querétaro, Querétaro de Arteaga, México Valeo A tiempo completoValeo is a technology company that designs innovative solutions to transform mobility. As a leading automotive supplier, we partner with global automakers and new mobility actors worldwide. Our vision is to create a greener and more secure mobility through solutions focusing on intuitive driving and reducing CO2 emissions.We are looking for an experienced...
-
Senior Quality Assurance Manager
hace 3 semanas
Santiago de Querétaro, Querétaro de Arteaga, México Gerresheimer A tiempo completoGerresheimer: A Global Leader in Specialty GlassWe are a leading global partner to the pharmaceutical and healthcare industry. With our specialty glass products, we contribute significantly to medical progress around the world.About the Role:We are currently seeking an experienced Senior Quality Assurance Manager to join our team at Gerresheimer.Job...
-
Senior Quality Assurance Manager
hace 3 semanas
Santiago de Querétaro, Querétaro de Arteaga, México Lear Corporation A tiempo completoLear Corporation, a global leader in Seating, Electrical and Electronic Systems, has an exciting opportunity for a Senior Quality Assurance Manager to join our team.We are seeking a highly motivated and experienced professional to lead our quality team and ensure the delivery of high-quality products to our customers.About Lear:Lear is a global leader in...
-
Senior Quality Assurance Manager
hace 4 semanas
Ciudad Apodaca, Nuevo León, México Grupo Prodensa A tiempo completoAbout the Role:We are seeking a seasoned Senior Quality Assurance Manager to join our team in Apodaca, Nuevo León.About Us:At Grupo Prodensa, we pride ourselves on being a leading Canadian sports equipment manufacturer with a strong presence in Mexico. Our commitment to excellence is reflected in our products and services, and we're looking for a talented...
-
Quality Manager
hace 6 meses
México Eaton A tiempo completoEaton’s IS AER FED division is currently seeking a Quality Manager. **What you’ll do**: **Job Summary** The Quality Manager plays a crucial role in defining, executing, and implementing the Strategic Quality Plan, Goals, and Objectives at the operational level. They work closely with plant quality teams and represent group management for the Quality...
-
Ciudad de México, Ciudad de México Schneider Electric Gruppe A tiempo completoJob DescriptionSchneider Electric Gruppe seeks an experienced Senior Quality Assurance Manager in Manufacturing to lead quality control processes and drive continuous improvement. Key responsibilities include ensuring customer requirements are met, coordinating with quality teams, and implementing Process Control Plans. The ideal candidate will have 5+ years...
-
Senior Cost Manager
hace 1 mes
Ciudad de México, Ciudad de México Turner & Townsend Group A tiempo completoCost Management is a key function in the delivery of successful projects. At Turner & Townsend, our team of experts provides cost management services to help our clients achieve their goals. As a Senior Cost Manager, you will play a critical role in delivering these services, working closely with clients, consultants, and contractors to ensure that projects...
-
Quality Manager
hace 7 meses
México Lear Corporation A tiempo completoLocation: Torreon, COA, MX**Quality Manager**: **Quality Manager** **Job based in Torreon, Matamoros, Coah. Torreon I Plant, E-Systems division** Lear Corporation is the leading Tier 1 automotive supplier serving all the world's major automotive manufacturers with our world-class automotive seating and automotive electrical products. Our products are...
-
Senior Quality Development Manager
hace 6 días
Ciudad Apodaca, Nuevo León, México Regal Rexnord A tiempo completoJob OverviewWe are seeking a highly skilled Senior Quality Development Manager to join our team at Regal Rexnord.About the RoleThis is a senior-level position responsible for leading and deploying strategic and tactical Supplier Quality and Development initiatives across the global supply base. The successful candidate will have a strong background in...
-
Chief Quality Operations Director
hace 1 semana
Ciudad de México, Ciudad de México Eastek International Corporation A tiempo completoJob SummaryWe are seeking a seasoned Senior Quality Manager to lead the implementation of advanced quality strategies and maintain quality standards at our international facilities in Mexico, Dong Guan, and Malaysia, as well as our centralized offices in the United States of America.
-
Senior Operations Quality Manager
hace 1 mes
Ciudad Apodaca, Nuevo León, México Celestica A tiempo completoJob Summary:Celestica is seeking an experienced Senior Team Leader, Operations Quality to join its team. This role will provide direct supervision and training to employees, focusing on quality performance, attendance, and disciplinary actions. The ideal candidate will have strong knowledge of product quality requirements, manufacturing processes, and ISO...
