Process Excellence and Digital QMS Quality Partner

hace 1 mes

España Roche A tiempo completo

The Position
Who We Are
At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all.
We do this today to build a better tomorrow.
Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts.
Quality is every patient’s right and every employee’s responsibility.
Role Purpose
As a Digital QMS Quality Partner you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments.
You are responsible for building and developing your capabilities to contribute more to the team, customers, and patients.
You apply new approaches to improving your work to enhance established processes, reduce costs, or mitigate significant compliance issues within your area of influence.
You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle.
You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.
You will be responsible to:

Contribute to implement and maintain the Quality Management System for Roche Information Solutions (RIS), which consists of a portfolio of standalone software for medical or health purposes.
Quality management of documents, processes, and support for audits and certifications applicable to RIS products.
Contribute to compliance activities required by regulations and standards for In-Vitro Diagnostics and Medical Device Manufacturers of standalone software products to assure a sustainable state of compliance.
Participate in continuous improvement, integration, harmonization of the Quality Management System, Management Review preparation, key performance indicators, Audit and Inspection readiness, and Change Management.
Participate in regional or global cross-functional meetings/initiatives where it may take a leading role.
Interface with colleagues from Quality, Regulatory, including auditing and post-market Chapters, R&D, Supplier Quality, and Training Chapter to perform the job.
Build and maintain strong partnerships with colleagues and business partners to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

Additional tasks:

Can coach and train quality professionals with less experience and provide guidance.
Collaborate to audit readiness for internal and external audits.
Act as a learning expert in defining and maintaining all required training according to the roles and responsibilities.
Support in change control methodology and documentation.
Support investigation or documentation of non-conformities or CAPA.
Identifying and escalating issues as they arise and able to provide adequate solutions.

What else do you have in your toolbox:

2-5 years of working experience
Bachelor’s/Master's degree in Life Science, Data Science, or related subject or equivalent experience.
Knowledge of Regulations and Quality Management Systems in Health Care (Pharmaceutical or Medical Devices).
Specific knowledge on ISO13485, ISO14971, IEC62304, IEC 82304, and legislation for software as medical device will be an advantage.
Able to initiate daily activities independently with limited guidance or supervision.
Good communication skills.
Has courage to make decisions within the scope of responsibility.
Is able to drive innovation within their own area of influence.
Is able to contribute by participating in large/global cross-functional or cross-chapter squads where it may take a leading role.
Proficient user of IT tools.
Advanced level of English. Other languages are an advantage.

Locations:
We offer a hybrid model with a lot of flexibility between the Sant Cugat del Valles office and the home office.
What else:
This role offers a competitive salary, plus an excellent benefits package that includes (among others):

Fascinating opportunities for your professional growth.
Additional holidays per labor agreement.
Wide range of options and platforms for learning and development.
Agile and flexible working policy, working from home.
An exceptional and modern office space (canteen, parking, and free coffee).
Private medical insurance.
Pension plan.
Life insurance.
Roche stock options.

Please check the following link to know more about our benefits.
As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.
At Roche, diversity and inclusion are essential values for our success. We have a special interest in integrating people with disabilities into our teams.
If you have a disability, for us it is a plus, and we have special benefits for you: Go ahead and join us

#J-18808-Ljbffr

  • Quality And Process Excellence Lead

    hace 2 semanas

    España buscojobs España A tiempo completo

    Educational QualificationBE / B Tech / MBA / B.Stat from a Premier InstituteSkills (Must Have)Program management & change managementProblem solving tools / analytical skillsExcellent communication / interpersonal, facilitation skillsHigh energy level, confident, assertive and team playerExperience (Minimum)Consulting ExperienceMinimum 2 years as Quality &...

  • Quality And Process Excellence Lead

    hace 3 semanas

    España Tasq Staffing Solutions A tiempo completo

    Educational Qualification BE / B Tech/ MBA/ B.Stat from a Premier Institute Skills ( Must Have) · Programmanagement & change management · Problemsolving tools/ analytical skills · Excellentcommunication / interpersonal, facilitation skills · High energylevel, confident, assertive and team player Experience ( Minimum) · ConsultingExperience · Minimum...

  • Associate Director, R&D Quality Systems, Strategy, And Excellence

    hace 4 semanas

    España buscojobs España A tiempo completo

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description : The Associate Director of R&D...

  • Senior IT Business Analyst

    hace 1 mes

    España Galderma S.A. A tiempo completo

    Senior IT Business Analyst - eDMS and QMSGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and...

  • Senior IT Business Analyst

    hace 3 semanas

    España Galderma A tiempo completo

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...

  • Senior IT Business Analyst

    hace 1 mes

    España Galderma A tiempo completo

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...

  • Senior IT Business Analyst – Edms And Qms

    hace 4 semanas

    España GALDERMA A tiempo completo

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...

  • Senior IT Business Analyst – eDMS and QMS

    hace 1 mes

    España Galderma A tiempo completo

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...

  • Quality Systems Engineer

    hace 3 días

    España Schneider Electric A tiempo completo

    Job Description:The Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and...

  • Quality Systems Engineer

    hace 2 semanas

    España buscojobs España A tiempo completo

    The Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and customer...

  • Quality Systems Engineer

    hace 3 semanas

    España Schneider Electric Global A tiempo completo

    The Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and customer...

  • Quality Assurance

    hace 1 semana

    España buscojobs España A tiempo completo

    Merlin Digital Partner: Your Strategic Talent Partner in the Digital EcosystemAt Merlin, we are a leading talent acquisition consultancy with over 20 years of experience in the digital world. We proudly support startups, scaleups, and corporates in more than 10 countries, helping them find the talent they need to thrive across 15+ areas of...

  • Quality Systems Engineer

    hace 1 mes

    España oilandgas.org.uk A tiempo completo

    The Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and customer...

  • Digital Talent Acquisition

    hace 1 mes

    España Merlin Digital Partner A tiempo completo

    Merlin Digital Partner is a tailor-made digital recruitment company for startups, scale-ups and corporates. We were born in Tech Barcelona where we established one of our main offices. We are a dynamic and young team, tech & digital lovers, and truly committed with our candidates. We really believe in long-term relationships and not only in technical...

  • Director, Quality and Regulatory

    hace 2 semanas

    España Thermo Fisher Scientific A tiempo completo

    Thermo Fisher Scientific - Barcelona, SpainNegotiableFull-Time1 positionWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your...

  • TA Process Excellence Manager, EMEA Stores TA, ASSET

    hace 4 semanas

    España ENGINEERINGUK A tiempo completo

    TA Process Excellence Manager, EMEA Stores TA, ASSETDESCRIPTIONAt Amazon, we're working to be the most customer-centric company on earth. To get there, we need exceptionally talented, bright and driven people. We are looking for a TA Process Excellence Manager to be a part of our Program Management team based in Barcelona, Spain. The TA Process Excellence...

  • Sap Business Partner Quality Management

    hace 3 semanas

    España Tasq Staffing Solutions A tiempo completo

    The SAP Business Partner Quality Management (QM) will be working in the Digital Solutions team under the supervision of the Head of Enterprise Applications and the Programme Manager. He/she will work closely together with the GC Global SAP team members, Digital Solutions team, globally located Business Process Experts (BPEs), end users, externally hired...

  • Sap Business Partner Quality Management

    hace 2 semanas

    España buscojobs España A tiempo completo

    The SAP Business Partner Quality Management (QM) will be working in the Digital Solutions team under the supervision of the Head of Enterprise Applications and the Programme Manager. He / she will work closely together with the GC Global SAP team members, Digital Solutions team, globally located Business Process Experts (BPEs), end users, externally hired...

  • QMS Manager

    hace 1 mes

    España Centrient Pharmaceuticals Netherlands A tiempo completo

    Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.With our commitment...

  • Quality Systems Manager

    hace 1 mes

    España Albelli A tiempo completo

    About the role As a Quality Systems Manager at Albelli Photobox Group, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with...