Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $35 billion and approximately 110,000 employees in more than 50 countries.
Our mission is to enable our customers to make the world healthier, cleaner and safer.
We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.
Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
Reporting to the Director of Quality & Regulatory Affairs for Thermo Fisher Diagnostics (TFD), the **Sr. Quality and Regulatory Manager is responsible for supporting the establishment of a world-class QARA function for TFD, a $700 million, multi-national business operating across the breadth of the European commercial region.
**
**This role is responsible for aiding the formation of strategy and providing operational direction and leadership to drive the successful creation, implementation and maintenance of one aligned quality system across the TFD commercial entities - including UK, Ireland, Spain, Portugal, Italy, France, Netherlands, Belgium, Norway, Sweden, Denmark, Finland, Germany, Austria and Switzerland - established in the business.
**
Supporting TFD's commercial services - sales and marketing, distribution, importation, warehousing, customer services and field service operations - to the multiple divisions within the Specialty Diagnostics Group (SDG), the role is accountable for ensuring the quality system of TFD interfaces seamlessly with those of the Divisions it supports and meets the needs of local and international regulations and standards, such that compliance risks are understood and mitigated to avoid impact to the business.
The incumbent requires significant experience in leading operational quality matters within a medical device business as well as recent experience working with global regulatory authorities to ensure the quality system is maintained and effective and that products commercialized within the region are appropriately registered.
**This position will lead all aspects of our ISO 13485 and ISO 9001 Quality and Regulatory processes, which covers sales and marketing, distribution, import, warehousing, customer services and technical field service operations for diagnostics medical device products and related industries**.
**Summary of Key Responsibilities and Function**
Responsible for leading cluster Quality Management Representatives and overarching activities of the Quality Assurance/Regulatory Affairs Department relating to processes such as SOP Management, Document and Data Management, Change Control Management, Non-Conformance Reporting (NCR), Corrective and Preventative Action (CAPA), Internal Audit, System Administration, Quality Metrics & Key Performance Indicator management, and regulatory requirements for the Medical Device Regulations (MDR) and In-vitro Diagnostic Regulations (IVDR).
The Senior Quality & Regulatory Manager plays an active role in establishing plans and business objectives.
**Key Responsibilities**:
- Lead, coach, develop, and support a quality and regulatory team, with reports based in various countries throughout Europe.
- Ensure TFD compliance with MDR and IVDR Articles 13 and 14
- Responsible for monitoring, ongoing maintenance and certification of the TFD-QMS, aligned across all TFD entities in the commercial regions it operates within.
- Reviews and continuously improves quality and compliance operating controls to ensure ongoing compliance with applicable regulations, standards, corporate and customer requirements
- Ensure the processes needed for the Quality Management System (QMS) are established, implemented, maintained, and led, including but not limited to document control, NCR, CAPA, change control, internal audit, management review, analysis of data, and complaints.
- Understand the internal customer requirements and ensure these are supported by the QMS, whilst maintaining compliance
- Facilitate the regular reporting of key data; including lead and lag indicators, trending, and other data analytics for key quality and business metrics.
- Develop and implement strategic QARA plans to support the growth of the business
- Partner and collaborate with other Thermo Fisher Scientific business units to find opportunities and solutions related to QARA matters impacting the business
- Develop an outstanding QARA team, who will exceed targets and deliver outstanding results including the long-term talent pipeline
- Embed a culture of 'right the first time' and continual improvement throughout all functions of TFD
**Minimum Requirements**:
- 8 years+ experience in Quality Assurance and/or Regulatory Affairs
- 4 years+ people management experience
- Experience with ISO 13485 or ISO 9001