Director, Quality Systems and Compliance

Vor 3 Tagen

Home Office, Schweiz Thermo Fisher Scientific Vollzeit

**DIVISION OVERVIEW**

The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select in vitro diagnostic (IVD) market segments and has been a trusted supplier in the IVD industry for over 40 years. CDD provides products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening and more. Additionally, the division provides advanced laboratory instrumentation and high-throughput laboratory automation equipment for use in a variety of laboratory settings. CDD recognizes more than $1BM in annual revenue and employees 2,400 Thermo Fisher Scientific colleagues across the Americas, Europe and Asia, with primary global business unit locations in the United States (California and Virginia), Germany, Finland and France. Products are offered through direct sales, regional distributors, and OEM partnerships.

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Are you a dynamic quality / regulatory professional looking to make a major impact in an exciting organization? If the answer is yes, a role in Thermo Fishers Clinical Diagnostics Division (CDD) may be the perfect fit for you

The Director, Division Quality Systems & Compliance is responsible for monitoring compliance risk across the business, defining and rigorously assessing quality data to identify opportunities to reduce risk or improve performance.

In this role, you will monitor regulatory compliance trends, provide quality systems and compliance insight and direction to the business Leadership Team and plan, resource and lead Division-wide initiatives to simplify and harmonize the QMS, ensuring compliance, delivering productivity and removing barriers to execution across all CDD Business Units.

The role directly supports the CDD Vice President of Global Quality Assurance and Regulatory Affairs in development, maintenance and implementation of the strategic plan (STRAP) for the function, improving capabilities to align with the evolving needs of the business.

The Director, Division Quality Systems and Compliance will lead a Division Quality Systems function of approximately 5 quality professionals.

**Key Responsibilities**:

- Drive quality system harmonization and simplification across the Division in targeted, core sub-systems, leveraging internal and industry best practices to achieve sustainable, compliant and efficient performance.
- Establish Division-level dashboards of meaningful leading and lagging quality system performance indicators. Use data to identify areas of risk / opportunities for improvement and provide Project Management capacity and leadership for strategically important, division-wide QARA projects to resolve.
- Hold global CDD Quality functions accountable for delivering on agreed strategies and tactics.
- Establish and lead a Division-wide Management Review process, rolling up quality system performance across all Business Units, to inform the CDD Leadership Team of significant compliance risks and drive action to ensure no regulatory compliance interruption to operations.
- Support all BU’s with regulatory compliance interactions with FDA and other health agencies, to ensure expectations are met.
- Provide direct support to the CDD Vice President of Global Quality Assurance and Regulatory Affairs in establishing and executing a rolling 5 year Strategic Plan for the function, to maintain compliance and deliver increased value to the business.
- Collaborate with Financial partners to lead annual operating planning for the Division function.
- Partner with IT and BU leaders to establish and drive implementation of a digital roadmap for QARA, realizing digital tools that support the Strategic Plan.
- Establish and manage an active portfolio of Practical Process Improvement (PPI) QARA projects across the Division to ensure compliance, drive productivity and remove barriers to execution.
- Collaborate and effectively engage with the Corporate Quality / Regulatory Council on business-wide Quality initiatives, to ensure alignment and support.
- Act as an advocate for Quality in all interactions with business peers, fostering a culture of personal quality within the Division.
- Perform all job duties in a manner that is consistent with Thermo Fisher Scientifics code of ethics and 4-I values (Integrity, Intensity, Innovation and Involvement).

**QUALIFICATIONS**:

- Minimum 10 years of experience in a medical device / pharmaceutical industry in a quality / regulatory affairs role, with minimum 5 years experience in a leadership role of same.
- Undergraduate degree in scientific discipline required; advanced degree preferred.
- Experienced in leading fundamental change or process improvement on a global basis moving toward a global harmonized / simplified model.
- Experience interpreting and working under the regulations governing medical device / drug products and familiar with the compliance expectations and processes employed by the global agencies (FDA, IVDR Notified Bodies, PMDA, NPMA, ANVISA, He

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