Sr Manager, Division Quality Systems and
vor 7 Monaten
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Join our distributed team of more than 100,000 colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
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 sophisticated laboratory instrumentation and high-throughput laboratory automation equipment for use in a variety of laboratory settings. We search for a
**Senior Manager Quality Systems & Compliance**
**Location: Europe, remote**
You are responsible for oversight of targeted quality system processes, such as Change Control, Complaint Handling or CAPA, for supervising regulatory compliance risk related to those quality system processes across the business, for defining and rigorously assessing quality data to find opportunities to reduce risk or improve performance.
In this role, you will supervise quality regulatory compliance trends, connect with other enterprise groups, functions, and programs, provide quality systems and compliance insight and direction to business units and the business Leadership Team, ensuring compliance, identifying and driving cost reductions, and focusing on continuous improvements.
**Your responsibilities**:
- Drive quality system harmonization and simplification across business units in targeted, core sub-systems, such as Change Control, Complaint Handling or CAPA, improving internal processes based on industry standard methodologies to achieve balanced, compliant, and efficient performance.
- Define and implement structured approach to improve the quality culture, using tools such as Making Quality Personal (MQP). Act as an advocate for Quality in all interactions with business peers, encouraging a culture of personal quality within the Division.
- Continuously improve Division-level dashboards, establish, and maintain meaningful leading and lagging quality system performance indicators. Identify areas of risk / opportunities for improvement and provide Project Management capacity and leadership for strategically important, division wide QARA projects to resolve.
- Provide information to Division-wide Management Review process, to inform the CDD Leadership Team of significant compliance risks and drive action to ensure no regulatory compliance interruption to operations.
- Establish and implement an active portfolio of Practical Process Improvement (PPI) QMS projects across the Division to ensure compliance, drive efficiency and remove barriers to execution.
- Partner with IT and BU’s to establish and drive implementation of and/or alignment on digital tools used to handle key quality system processes.
- Collaborate and connect with the Corporate Quality / Regulatory Council on business-wide QMS initiatives, to ensure alignment and support
- Travel requirement: approximately 25% regional and international travel is encouraged.
**Your qualifications**:
- Undergraduate degree in scientific field required; advanced degree preferred
- At least 7 years of experience in a medical device / pharmaceutical industry in a quality / regulatory affairs role
- 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, ANVISA, Health Canada etc.).
- Quality lead auditor certificate preferred.
- Knowledge of Six Sigma tools such as FMEA, DMAIX, Value Stream Map and Pareto Analysis preferred.
- Excellent collaboration and communication skills in English.
- Ability to get results in a matrixed organization, especially having representatives from different cultures come together, adopting diversity.
- Strong demonstration of leadership capabilities with experience in leading programs and projects.
- Technically savvy using IT databases and familiarity with commercial digital tools.
**We offer** competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fi
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