Sr. Director, Quality & Regulatory Brno

Sr. Director, Quality & Regulatory

When you’re part of the team at our company, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make important contributions to the world.
All of our employees share our important 4-I Values - Integrity, Intensity, Innovation and Involvement. Our capacity to grow year after year is driven by our ability to attract, develop and retain outstanding people who will bloom in our environment and share in our desire to improve people by enabling our customers to make the world healthier, cleaner and safer.
In Thermo Fisher Scientific Brno we develop and produce high-tech electron microscopes and spectrometers. Our devices assist in the research of ZIKA virus, HIV or enable the diminution of mobile phones. Our work makes the world healthier, cleaner, and safer. We are the biggest producers of electron microscopes worldwide and we have more than 70 years long tradition. You can find among us many experts in physics, electronics, software, mechanical engineering, and logistics.
**Position Summary**:
At Thermo Fisher Scientific, Quality is at the heart of everything we do! The Senior Director, Quality and Regulatory will lead the Materials and Structural Analysis Division (MSD) quality assurance and regulatory systems and strategies to support the business. Reporting to the MSD Vice President of Operations, this position has a powerful impact on our business and customers by providing quality leadership and ensuring strategic quality planning, regulation monitoring, and Quality Management System (QMS) improvement activities are established and maintained according to business needs while meeting all regulatory requirements.
**Key Responsibilities**:
- Build and drive the quality & regulatory and vision, strategy and annual goals and objectives for MSD.
- Lead and inspire a successful international team by recruiting and developing strong leaders, establishing performance expectations, and providing development and training opportunities.
- Drive operational excellence by successfully using continuous improvement skills and tools to prioritize and drive projects and standardization across the network to improve product quality, reduce costs of poor quality, and align with business objectives.
- Establish network wide QA priorities and key objectives to improve compliance with regulations and the global Quality Management System.
- Partner with the Business Unit and functional leaders to drive a more customer centric focus on product quality.
- Ensure global QMS training is effective and operates within the required regulatory guidelines.
- Uphold awareness of applicable standards and regulations, and supervise activities related to changes in the standards as well as the regulations.
- Collaborate with corporate, group and divisional partners to identify quality issues, conduct regular audits, and complete special projects.
- Build strong working relationships across organizations and geographies and engages with business partners to define existing gaps and future requirements.
- Ensure effective management and drive continuous improvement of the global Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, and NPDI.
- Support the commercialization of New Product Introductions by working with cross functional team members.
- Collaborate with regulatory organizations to ensure compliance to applicable regulations.
- Lead executive quality management reviews.
- Other miscellaneous duties as assigned.
**What will you need?**
Qualifications and experience:
- Bachelor’s degree in engineering or other relevant fields
- A minimum of 8 years preferred of multidimensional quality and regulatory experience
- Puts the customer at the front of every decision, including work prioritization, resource investment, and process improvement.
- Shown success implementing quality systems that provide the critical controls as defined by regulatory, marketplace and our customers.
- Consistent track record of building and leading teams. Designs effective organizations and develops adaptable leaders.
- Clear view of the mechanisms required to run a quality assurance organization efficiently and effectively.
- Ability to demonstrate flexibility and work in the grey area’s to achieve win-win outcomes for the customers.
- Proven ability to run multiple projects simultaneously while prioritizing those that drive to the biggest outcome.
- Ability to lead from and across remote locations.
- Ability to travel 25% - 50% of the time.
**A selection of our benefits**:
- 5 weeks of vacation
- Pension allowance
- Annual bonus
- Flexible working schedule
Thermo Fisher Scientific offers employment with an innovative,

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