Director, Quality and Regulatory

vor 3 Wochen

Ecublens, Schweiz Thermo Fisher Scientific Vollzeit

When 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 career goals.

**Position Summary**:
The Director, Quality and Regulatory will oversee the High-Performance Chromatography Solutions (HPCS) and Software Business Unit quality system and quality assurance strategies. Reporting to the Vice President of Chromatography & Mass Spectrometry Division (CMD) QARA, this position will be responsible for ensuring the highest level of quality and compliance in our operations, products, and services. Your expertise and leadership will be instrumental in driving continuous improvement, implementing quality management systems, and ensuring regulatory compliance in a rapidly evolving industry. This role will provide leadership by ensuring strategic quality planning, regulation monitoring, and QMS integration/improvement activities are effectively established and maintained according to business needs.

**Key Responsibilities**:

- Build and drive a Quality vision and strategic objectives that aligns with our High-Performance Chromatography Solutions BU.
- Lead and inspire a strong global quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.
- Drive operational excellence by effectively using continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Product Quality, reduce costs of poor quality, and align with strategic objectives.
- Establish network wide QA priorities and key objectives to improve the compliance to regulations and the global Quality Management System.
- Ensure global QMS training is effective and operate within the required regulatory guidelines.
- Uphold awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation
- Assess product regulations and standards and the impact to meet global requirement
- Collaborate with corporate & divisional partners regarding quality issues, audits, and special projects
- Influence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.
- Ensure effective management of the global Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, NPDI.
- Drive the continuous improvement of Quality Management Systems, including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, and NPDI process support.
- Support the commercialization of New Product Introductions by working with cross functional NPDI team members.
- Collaborate with Regulatory organization to ensure compliance to applicable regulations.
- Lead executive quality management reviews.
- Other miscellaneous duties as assigned.

**Minimum Requirements/Qualifications**:

- Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred.
- Extensive experience (at least 5-10 years) in quality management preferably within the Life Sciences, Pharmaceutical Industry or software industry.
- Customer focus - Puts the customer at the front of every decision, including work prioritization, resource investment, and process improvement
- Quality systems - Ability to practically implement strong quality systems that provide the necessary controls as defined by regulatory, marketplace and our customers.
- Building a team - Builds a strong team and has a strong capability to marry strategy, organizational structure, and capable leaders
- Operational execution - Clear view of the mechanisms necessary to manage a quality assurance organization efficiently and effectively
- Ability to demonstrate flexibility and manage multiple complex projects simultaneously
- Ability to manage from and across remote locations
- Ability to travel up to 30%

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

  • Director, Quality and Regulatory

    vor 3 Wochen

    Ecublens, Schweiz Thermo Fisher Scientific Vollzeit

    When 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 career goals. **Position Summary**: The Director, Quality and Regulatory...

  • Director, Quality and Regulatory

    vor 4 Wochen

    Ecublens FR, Freiburg, Schweiz ThermoFisher Scientific Vollzeit

    Job DescriptionWhen 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 career goals.Position Summary:The Director, Quality and Regulatory...

  • Test Team Leader

    vor 1 Woche

    Ecublens, Schweiz Swiss ELS Vollzeit

    _The Test Team Leader will be a key player for Sigi design verification, ahead of clinical trials and regulatory submissions._ - These tests, carried out according to ISO 13485 requirements, will demonstrate functionality, efficiency and sufficient reliability of the Sigi system to build the technical file of the product, as necessary to submit requests to...

  • Head of Country Programmes

    vor 2 Wochen

    Ecublens, Schweiz Medair Vollzeit

    **Location**: Global Support Office (GSO) position based in Ecublens, Switzerland. Travel for up to 2 months a year. Swiss or eligible EU citizens, or those with a valid work permit for Switzerland, can apply.**Starting Date & Initial Contract Details**: As soon as possible. Full-time, open-ended contract. **Role Overview**: Managing, empowering and...

  • Strategic Market Business Development Director

    vor 4 Wochen

    Ecublens, Schweiz Thermo Fisher Scientific Vollzeit

    **Strategic Market Business Development Director** **R-01225134*** **The position can be based anywhere. East Coast preferred.** Thermo Fisher Scientific is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating...

  • Strategic Market Business Development Director

    Vor 3 Tagen

    Ecublens, Schweiz Thermo Fisher Scientific Vollzeit

    **Strategic Market Business Development Director** **R-01225134*** **The position can be based anywhere. East Coast preferred.** Thermo Fisher Scientific is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating...

  • Technicien Test

    vor 1 Woche

    Ecublens, Schweiz Swiss ELS Vollzeit

    The Test Technician will be a key player for Sigi design verification, ahead of clinical trials and regulatory submissions. These tests, carried out according to ISO 13485 requirements, will demonstrate functionality, efficiency and sufficient reliability of the Sigi system to build the technical file of the product, as necessary to submit requests to...

  • Research and Development Scientist in Biology

    vor 4 Wochen

    Ecublens, Schweiz bNovate Technologies SA Vollzeit

    Grow with us and join our R&D team!We are seeking a highly motivated R&D Scientist with expertise in water microbiology and bio-assay development to join our dynamic and friendly team. The successful candidate will play a key role in the development of novel instruments for the detection of bacteria in water, contributing to enhanced safety and water quality...

  • Research and Development Scientist in Biology

    vor 3 Wochen

    Ecublens, Schweiz bNovate Technologies SA Vollzeit

    Grow with us and join our R&D team!We are seeking a highly motivated R&D Scientist with expertise in water microbiology and bio-assay development to join our dynamic and friendly team. The successful candidate will play a key role in the development of novel instruments for the detection of bacteria in water, contributing to enhanced safety and water quality...

  • Mechanical Engineering Team Leader

    vor 1 Woche

    Ecublens, Schweiz Swiss ELS Vollzeit

    _The Mechanical Engineering Team Leader is responsible for the development, testing, verification and validation of all mechanical parts of insulin patch pump. The key goal is to successfully transfer the design to manufacturing after demonstration of reliability. She/he sets the direction and leads daily the mechanical engineering teams from pre-series to...

  • Digital Transformation Architect

    vor 2 Wochen

    Ecublens, Schweiz Medair Vollzeit

    **Location**: This is a GSO position, based in Ecublens, Switzerland. Swiss or eligible EU citizens, or those with a valid work permit for Switzerland, can apply. Remote work could be possible with conditions.**Starting Date & Initial Contract Details**: As soon as possible. Full-time, 12 months. **Role Overview**: Provide input for the International...

  • Research And Development Scientist In Biology

    vor 4 Wochen

    1024 Ecublens, Schweiz bNovate Technologies SA Vollzeit

    Ecublens, SuissePermanent, 80-100% YOUR TASKS Contribute to the development of innovative technology platforms for detecting bacteria in water using bioanalytical tools and advanced monitoring techniques.Conduct cutting-edge research and development with a focus on water science, microbiology and biochemistry.Design and optimise assays, reagents and...

  • Technical Customer Advisor

    vor 4 Wochen

    Ecublens, Schweiz Global Job Services Vollzeit

    **Job Summary**: In this role, you will ensure a high level of customer satisfaction through your competent customer advice and your conscientious and efficient way of working, while at the same time making an important and valuable contribution to the successful growth of the company. **Your main tasks are**: - Providing technical customer advice on the...

  • CTO (W/m/d) 80% - 100%

    vor 2 Wochen

    Ecublens, Schweiz Migros Online Vollzeit

    Join us as a CTO and be the visionary leader shaping our technical landscape. A top leader with an engineering mind, a product focus and a grasp of logistics. Your role is critical in aligning engineering with our company and product strategy, helping to accelerate how we deliver and capture value. **Place of work**: **Migros Online**: Migros Online SA -...

  • Technical Customer Advisor

    vor 2 Monaten

    Ecublens, Schweiz HIKMA-SOLUTIONS Vollzeit

    Hikma-Solutions is seeking for one of its clients a "Technical customer advisor - sales support". You will play a pivotal role in customer satisfaction by providing competent advice and working conscientiously and efficiently, thereby making a significant and valuable contribution to the successful growth of the company. Tasks Providing technical...

  • Technical Customer Advisor

    vor 2 Monaten

    Ecublens, Schweiz HIKMA-SOLUTIONS Vollzeit

    Hikma-Solutions is seeking for one of its clients a "Technical customer advisor - sales support". You will play a pivotal role in customer satisfaction by providing competent advice and working conscientiously and efficiently, thereby making a significant and valuable contribution to the successful growth of the company. Your main responsibilities will...

  • Project Manager

    vor 2 Monaten

    Ecublens, Schweiz Oratek Vollzeit

    Oratek, an engineering consulting company based in Ecublens, Switzerland, is seeking a skilled Project Manager to join our highly experienced and multidisciplinary team. As a Project Manager at Oratek, you will be responsible for overseeing the planning, execution, and delivery of projects, ensuring that they are completed on time, within budget, and to the...

  • Project Manager

    vor 2 Monaten

    Ecublens, Schweiz Oratek Vollzeit

    Oratek, an engineering consulting company based in Ecublens, Switzerland, is seeking a skilled Project Manager to join our highly experienced and multidisciplinary team. As a Project Manager at Oratek, you will be responsible for overseeing the planning, execution, and delivery of projects, ensuring that they are completed on time, within budget, and to the...

  • Project Manager

    vor 3 Wochen

    Ecublens, Schweiz Oratek Vollzeit

    Oratek, an engineering consulting company based in Ecublens, Switzerland, is seeking a skilled Project Manager to join our highly experienced and multidisciplinary team. As a Project Manager at Oratek, you will be responsible for overseeing the planning, execution, and delivery of projects, ensuring that they are completed on time, within budget, and to the...

  • Project Manager

    vor 3 Wochen

    Ecublens, Schweiz Oratek Vollzeit

    Oratek, an engineering consulting company based in Ecublens, Switzerland, is seeking a skilled Project Manager to join our highly experienced and multidisciplinary team. As a Project Manager at Oratek, you will be responsible for overseeing the planning, execution, and delivery of projects, ensuring that they are completed on time, within budget, and to the...