Compliance Manager
hace 3 meses
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
About Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. is a world-class company dedicated to enabling our customers to make the world healthier, cleaner, and safer. As a global leader in scientific research, we are committed to driving technological innovation, solving complex scientific challenges, and supporting patients in need. With a team of over 100,000 colleagues worldwide, we value diverse experiences, backgrounds, and perspectives, creating an inclusive and collaborative work environment.
**Compliance Manager - Quality Role**:
As a Compliance Manager at Thermo Fisher Scientific, you will play a key role in driving quality and compliance strategies and initiatives across the organization. Your primary focus will be to support quality delivery and compliance, optimizing processes, behaviors, performance, and audit readiness. With your expertise, you will interpret complex data, lead teams, and make sound business decisions. Additionally, you will provide mentoring and guidance to advance the vision of the department.
**Responsibilities**:
- Research and address issues using problem-solving methodology, documenting in accordance with ALCOA principles and tracking metrics related to quality and compliance activities.
- Lead quality and compliance processes, ensuring their successful execution and completion.
- Lead and/or participate in process improvement initiatives.
- Collaborate with representatives from other departments to maintain quality and timelines for compliance activities, such as client audits and procedural documents.
- Develop multifaceted support materials, presentations, and tools to support the department's remit and strategies.
- Provide training and mentorship to junior team members.
**Job Requirements**:
To excel in this role, you will need:
- A bachelor's degree or equivalent experience, along with relevant formal academic/vocational qualifications.
- Previous experience (comparable to 8+ years) that provides the knowledge, skills, and abilities to perform the job.
- Effective oral and written communication skills in English.
- Strong organizational and time-management skills.
- Extensive knowledge of the clinical trial process.
- Thorough understanding of ICH GCP and other relevant regulations and guidelines.
- Highly developed problem-solving skills, including root cause analysis and corrective/preventive action.
- The ability to work both independently and collaboratively in a team environment.
- Strong leadership skills and attention to detail.
- Proficiency in digital tools and software.
**Working Conditions and Environment**:
- This position is remote, allowing you to work from a home-based office environment with exposure to electrical office equipment.
- Occasional travel to office locations, both domestic and international, may be required.
**Physical Requirements**:
To perform this role, you should be able to:
- Work in an upright and/or stationary position for 6-8 hours per day.
- Make fast, simple, repeated movements of the fingers, hands, and wrists.
- Move around frequently and occasionally crouch, stoop, bend, and twist.
- Lift and carry objects, including luggage and a laptop computer, with a maximum weight of 15-20 lbs.
- Access and use various computer software.
- Communicate effectively and interact with diverse groups.
- Work independently with little guidance, requiring intense concentration and the ability to perform under stress.
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