Talent.com
Esta oferta de trabajo no está disponible en tu país.
Senior Director, Quality and Compliance

Senior Director, Quality and Compliance

TFS HealthScienceMadrid, Comunidad de Madrid, .ES
Hace 13 días
Tipo de contrato
  • Quick Apply
Descripción del trabajo

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Senior Director, Quality and Compliance - home based in any TFS European location.

About this role

As part of our Quality and Compliance team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior Director, Quality and Compliance is responsible for ­­­­­­­­­­­­­­­­­compliance control and inspection readiness across TFS, and will work according to company policies, SOPs, and regulatory requirements.

You will be accountable for strategy, performance / delivery, compliance and operational results of the Quality & Compliance department.

Key Responsibilities :

Compliance Oversight

  • Maintain expert-level knowledge of relevant regulations, GxP standards, and internal procedures.
  • Ensure company-wide compliance through proactive monitoring, communication, and implementation of regulatory requirements.
  • Lead integration of regulatory changes into the Quality Management System (QMS); oversee major quality events.
  • Advise stakeholders on compliance strategies and risk mitigation.
  • Define acceptable compliance thresholds in collaboration with executive leadership, monitor performance and address deviations.

Leadership and Strategic Management

  • Build and lead a high-performing efficient GCP-focused Quality & Compliance (Q&C) team aligned with business goals and strategy.
  • Oversee quality and compliance metrics reporting.
  • Ensure global procedures (e.g., SOPs) are current and compliant with ICH, GCP, and EU / US directives.
  • Optimize Q&C processes for efficiency and effectiveness.
  • Serve as Business System and Process Owner as assigned; maintain the Quality Manual and contribute to client / sponsor Quality Agreements.
  • Provide full line management for Q&C staff, including recruitment, performance evaluation, training, succession planning, and administrative oversight.
  • Mentor and coach team members; manage time reporting and expense tracking.
  • Ensure Q&C deliverables meet TFS quality standards, support whistleblowing procedures in coordination with Legal.
  • Contribute to cost modelling, pre-sales activities, RFPs / RFIs, and post-award documentation (e.g., MSAs) for quality / compliance services
  • Collaborate with senior leadership and cross-functional teams to foster a positive and productive work environment.
  • Audit Management

  • Develop and execute the Annual Audit Plan.
  • Lead internal and external audit activities, including preparation, hosting, and follow-up.
  • Review audit reports and provide strategic guidance to internal auditors and participating TFS staff.
  • Maintain robust documentation to support compliance and business continuity.
  • Regulatory Inspections

  • Manage and host regulatory inspections of TFS operations, and oversee response to regulatory findings
  • Coordinate preparation of investigational sites for inspection readiness.
  • Support client-related regulatory inspections.
  • Maintain comprehensive records to ensure inspection readiness and continuity.
  • Quality Management System (QMS)

  • Oversee the electronic QMS (eQMS), including controlled documents, quality issues, and CAPAs.
  • Ensure proper handling of complaints, potential serious breaches, fraud, and scientific misconduct investigations in line with SOPs.
  • Additional Responsibilities

  • Ensure vendor qualification and oversight in accordance with internal procedures.
  • Ensure Computer System Validation (CSV) activities and oversight in accordance with internal procedures
  • Perform other quality and compliance-related tasks as delegated.
  • Qualifications :

  • University / college degree in life science or equivalent
  • Minimum 10 years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.)
  • Minimum 10 years’ experience of auditing in two to three GxP areas
  • Minimum 10 years in compliance or relevant leadership role.
  • Excellent knowledge of GxP regulations and guidance. Awareness of global trends, and government policies in the clinical trials area.
  • Strong experience in driving the quality and compliance within CROs and their regulatory and business requirements
  • Strong leadership skills, problem-solving and team management
  • Extensive ability to deal effectively with inspectors, sponsors, and internal customers at all levels
  • Willingness and ability to travel
  • Excellent English verbal and written communication skills.
  • Fluency in other languages will be considered as an advantage
  • What We Offer

    We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

    A Bit More About Us

    Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

    Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

    Together we make a difference.

    Crear una alerta de empleo para esta búsqueda

    Director Quality • Madrid, Comunidad de Madrid, .ES

    Ofertas relacionadas
    • Oferta promocionada
    Quality Assurance Director

    Quality Assurance Director

    beBeeQualityMadrid, Comunidad de Madrid, España
    We are looking for a visionary leader to join our team as a Quality Assurance Director.In this role, you will oversee the entire quality management process across all global operations.Oversight of...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE)

    Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE)

    TFS HealthScienceMadrid, Comunidad de Madrid, España
    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journe...Mostrar másÚltima actualización: hace 3 días
    • Oferta promocionada
    SeniorTrainingandQualityDirector

    SeniorTrainingandQualityDirector

    beBeeQualityManagerMadrid, Madrid, España
    Overview Job Title : Customer Care Senior Training and Quality Director.Shape the Future of Digital Commerce as a key member of our team. Responsibilities Develop and implement comprehensive train...Mostrar másÚltima actualización: hace 16 días
    • Oferta promocionada
    Senior Specialist, Trade Operations & Compliance

    Senior Specialist, Trade Operations & Compliance

    Modernamadrid, madrid, España
    Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Continuous Improvement Director

    Continuous Improvement Director

    EFIMadrid, Comunidad de Madrid, España
    All of us at EFI are relentlessly focused on the growth and success of the print business.That’s why print providers worldwide turn to EFI to help build their brilliant future.Our worldwide team me...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Director, Quality Assurance And Compliance

    Senior Director, Quality Assurance And Compliance

    VeristatMadrid, Comunidad de Madrid, España
    Senior Director, Quality Assurance and Compliance.The Senior Director, Quality Assurance (QA) and Compliance is responsible for ensuring compliance with all relevant guidelines and regulations, ove...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    • Nueva oferta
    Director, Quality

    Director, Quality

    DIATERMadrid, Kingdom Of Spain, España
    Importante multinacional del sector industrial busca incorporar un / una profesional experimentado para ocupar el puesto de Quality Director. Incorporándote a una compañía referente dentro de su sec...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    Senior Consultant & Associate Director - Quantu...

    Senior Consultant & Associate Director - Quantu...

    HKAMadrid, Comunidad de Madrid, España
    HKA is a leading global consultancy in risk mitigation, dispute resolution, expert witness and litigation support.We anticipate, investigate and resolve complex challenges by harnessing world-leadi...Mostrar másÚltima actualización: hace 14 días
    • Oferta promocionada
    Senior Director Of Risk Management

    Senior Director Of Risk Management

    OracleMadrid, Kingdom Of Spain, España
    Oracle CS4I (Customer Solution for Industry) Food and Beverage delivers a wide range of software, hardware, and related services—along with a rapidly growing portfolio of cloud solutions—to enable ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Director, Operations

    Senior Director, Operations

    Telix Pharmaceuticals LimitedMadrid, Comunidad de Madrid, España
    Get AI-powered advice on this job and more exclusive features.Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerlan...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Space Systems Quality Lead

    Senior Space Systems Quality Lead

    beBeeAerospaceMadrid, Comunidad de Madrid, España
    Product Assurance Manager Opportunity.We are seeking a Product Assurance Manager to lead all product assurance matters across a new spacecraft program, for a rapidly evolving innovative satellite p...Mostrar másÚltima actualización: hace 12 días
    • Oferta promocionada
    Senior Manager / Director Of Regulatory Affairs

    Senior Manager / Director Of Regulatory Affairs

    G&L Scientificmadrid, madrid, España
    Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L Scientific team. This role focuses on cross-functional activiti...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Manufacturing Operations Director

    Senior Manufacturing Operations Director

    beBeeQualityExecutiveMadrid, Comunidad de Madrid, España
    This position requires a seasoned professional with extensive experience in quality management, particularly within the manufacturing sector. The ideal candidate will have a proven track record of d...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Continuous Improvement Director

    Continuous Improvement Director

    Electronics for ImagingMadrid, Comunidad de Madrid, España
    All of us at EFI are relentlessly focused on the growth and success of the print business.That’s why print providers worldwide turn to EFI to help build their brilliant future.Our worldwide team me...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Operational Innovations Director / Senior Manager

    Operational Innovations Director / Senior Manager

    Mantell AssociatesMadrid, Madrid, España
    Mantell Associates are proudly partnered with a leading CDMO in their search for a Director of Operations to join their senior leadership team. Director of Operations - Responsibilities : .Work alongs...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Project Management Launch & Portfolio Specialist

    Project Management Launch & Portfolio Specialist

    Xiromed, LLCAzuqueca de Henares, Castile-La Mancha, Spain
    Xiromed is a vertically integrated generic company focused on delivering high quality & value products to the US and some European markets. Xiromed’s vision is to be a high quality provider of gener...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Operational Excellence Director, Emea

    Senior Operational Excellence Director, Emea

    Johnson ControlsMadrid, Comunidad de Madrid, España
    As a Senior Operational Excellence Director, you will be part of the EMEA Systems (Installation) Functional team and report directly into the Senior Director for EMEA Systems, supporting the Busine...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Compliance Specialist

    Senior Compliance Specialist

    beBeeRegulatoryMadrid, Madrid, España
    At the heart of every successful organization lies a critical component : compliance.Key Responsibilities & Deliverables. Securing regulatory approvals for new prototypes, product copy, and artwork.C...Mostrar másÚltima actualización: hace 16 días