Svt Compliance Lead

hace 4 semanas


Ciudad de México Novasyte A tiempo completo

Job Overview

This position is responsible for direct interaction with internal customers to determine hardware, software and system requirements. Ensures SDLC, ASLM, FDA, and SOX compliance for IT Projects in every portfolio. The position will define and analyze system needs/problems; design and test standards and solutions, create SDLC documentation, and ensure validation documentation meets requirements

*CV must be sent in English*

Essential Functions
- Performs and oversees software project validation in line with departmental SOPs and guidelines.
- Ensures SDLC validation documentation content is complete, maintained and meets GxP/FDA requirements.
- Authoring and/or contributing to all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
- Assesses company’s computer systems and identifies any potential GxP or FDA Part 11 gaps
- Participates in regulatory audits and provides information on validation activities performed for Q2 computer systems.
- Providing standardized templates, guidance, and overall validation direction supporting various programs
- Reviews internal and external requirements and implements required processes as needed to meet expectations regarding Quality
- All other System Validation Team processes and tasks as needed

**Qualifications**:

- Bachelor's Degree in Computer Science, a related field or equivalent experience in a medical, clinical, pharmaceutical or analytical setting
- Over Five (5) years related experience in Software Validation in a medical, clinical, pharmaceutical or analytical setting
- Excellent communication skills in English
- Experience with FDA, GxP, Part 11 and SOX validation rules and regulations
- Ability to travel to Q2 Solutions sites for in-person audit support as required

Desired Technical Abilities
- HP ALM
- HP Quality Center
- Jira
- Software Validation
- SDLC

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.



  • Ciudad de México GE Vernova Legal A tiempo completo

    **Job Description Summary**: Role Summary/Purpose The Compliance Investigator will be responsible for leading investigations relating to potential violations of law or GE Vernova policy. Working with other stakeholders in Legal, Compliance, Controllership, HR and other areas, the Compliance Investigator will (1) lead investigations of policy concerns raised...

  • Compliance Lead

    hace 1 mes


    Ciudad de México ABBVIE A tiempo completo

    As the OEC leader in the local Affiliate you report through the AbbVie Office of Ethics & Compliance (OEC) Organization. You are responsible for providing leadership, direct oversight and enhancement of the Ethics & Compliance Program in Mexico. As OEC Manager you will be a full member of the local Affiliate Management Team (AMT) in Mexico and as such you...


  • Ciudad de México, Ciudad de México AXA Partners A tiempo completo

    AXA Partners Mexico is seeking for talented professionals to join our team as a Compliance Officer. The Compliance function is a key role in the organization to ensure the compliance with local and international regulations, as well as internal policies for the minimization and mitigation of compliance and reputational risks. Also, responsible for...


  • Ciudad de México Warner Bros. Discovery A tiempo completo

    **_Every great story has a new beginning, and yours starts here._** **_ Welcome to Warner Bros. Discoverythe stuff dreams are made of._** **Who We Are ** When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of...

  • Lead CRA.

    hace 3 semanas


    Ciudad de México PSC Industries A tiempo completo

    i Ad · Clinical Project Manager · Clinical Project Manager · Location : CDMX · Hybrid Work ( 3 office days a week) · Role description · To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budg ... i Ad Lead Cra i Ad Clinical Project Manager · Clinical Project...


  • Ciudad de México American Express Company A tiempo completo

    You Lead the Way. We’ve Got Your Back. At American Express, we know that with the right backing, people and businesses have the power to progress in incredible ways. Whether we’re supporting our customers’ financial confidence to move ahead, taking commerce to new heights, or encouraging people to explore the world, our colleagues are constantly...


  • México AXA A tiempo completo

    AXA Partners Mexico is seeking for talented professionals to join our team as a Compliance Officer. The Compliance function is a key role in the organization to ensure the compliance with local and international regulations, as well as internal policies for the minimization and mitigation of compliance and reputational risks. Also, responsible for...


  • Ciudad de México HSBC A tiempo completo

    Some careers have more impact than others. If you’re looking for a career where you can make a real impression, join our Global Service Center (GSC) HSBC and discover how valued you’ll be. We are currently seeking an experienced professional to join our team in the role of Compliance Assurance Manager This is a role within the Compliance Assurance...


  • Ciudad de México Amex A tiempo completo

    **You Lead the Way. We’ve Got Your Back.** At American Express, we know that with the right backing, people and businesses have the power to progress in incredible ways. Whether we’re supporting our customers’ financial confidence to move ahead, taking commerce to new heights, or encouraging people to explore the world, our colleagues are constantly...

  • Compliance Manager

    hace 1 mes


    México Angel Ventures A tiempo completo

    Who we are? Payclip is changing the way payments work in Mexico! We are empowering people to exchange value directly from a mobile device. Clip enables anyone to accept card payments, at any time, and anywhere by turning your smartphone or tablet into a card terminal. We're a well-funded quickly growing FinTech startup. We are the leaders in our market...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...


  • Ciudad de México Mastercard A tiempo completo

    Our Purpose We work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our...


  • Ciudad de México GroupM South America A tiempo completo

    We are a leading global company, with a presence in over 60 countries through our agencies Mindshare, EssenceMediacom, Wavemaker, and Nexus. We drive the growth of our clients by providing high-quality services, creating original and innovative ideas, and offering solutions through a unique understanding of media, technology, and data. Our work can only be...


  • Ciudad Apodaca, N.L., México Johnson Controls International A tiempo completo

    He / She will be responsible for support our Center of Excellence with the following focus: Responsible to ensure the compliance of local and international transactions for all JCI Business units in LATAM region. Overall Compliance for programs and certifications for all LATAM sites. External Trade Compliance Audit Management for all LATAM sites. Among...


  • México DiDi Global A tiempo completo

    Company Overview: DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...

  • Qlik Tech Lead

    hace 1 mes


    Ciudad de México Talan A tiempo completo

    **A propos de Talan** Talan is an international advisory group on innovation and transformation through technology, with 5000 employees, and a turnover of 600M€. We offer our customers a continuum of services to support you at each key stage of your organization's transformation, with 4 main activities: - CONSULTING in management and innovation :...


  • Ciudad de México DiDi Global A tiempo completo

    Company Overview DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...


  • Ciudad de México HSBC A tiempo completo

    If you’re looking for a career where you can make a real impression, join our Global Service Center - HSBC and discover how valued you’ll be. We are currently seeking an experienced professional to join our team in the role of Product Operations Compliance Assurance Manager This is a role within Compliance Assurance (CA), which provides assurance...

  • Software Test Lead

    hace 23 horas


    Ciudad de México Sabenza IT A tiempo completo

    Software Test Lead Testing, IT Eastern Cape – South Africa One of the leading global suppliers of Premium and Luxury Cars and one of the world’s largest manufacturer of commercial vehicles, Seeks the expertise of a Software Test Lead to join their Dynamic team. Minimum Qualification & Experience: NQF 6 Required Minimum 5 years work...


  • Ciudad de México HSBC A tiempo completo

    If you’re looking for a career where you can make a real impression, join our Global Service Center (GSC)- HSBC and discover how valued you’ll be. We are currently seeking an experienced professional to join our team in the role of Manager US Compliance Services Governance and Support The Enterprise Compliance team in Mexico provides direct support...