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Compliance Manager

4 months ago

Austin, United States Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

**Location/Division Specific Information**:
North America

Remote based role, but requires some travel

**Discover Impactful Work**:
As a Compliance Manager within the Quality Investigation and Support team, you will lead complex, multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. You will identify issues impacting quality and/or regulatory compliance, determine root cause of non-conformance and develop strategies to address issues. You may perform technical document review and other GxP activities in support of project work or company process. This role plans and delivers billable quality services for clients and projects and may serve as the client contact.

**A day in the Life**:

- Leads investigations into significant quality issues
- Leads directed site audits, facility, vendor and/or sub-contractor audits
- Supports client audits and regulatory authority inspections
- Conducts inspection preparation activities and provides training to investigator site and CRG personnel
- Manages, supports, and reports on the outcomes of regulatory inspections of investigator sites, clients, and CRG
- Collaborates with investigator site staff and clients on development and/or review of responses to regulatory authority inspection findings
- Prepares and presents audit/inspection findings and/or other related information at departmental, internal operations or client meetings
- Participates in identification, assessment, action planning and reporting of serious breaches of GCP and protocol
- Leads and/or participates in process/quality improvement initiatives
- Provides mentorship and guidance to junior auditors

**Keys to Success**:
**Education**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification

**Experience**:

- 5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
- ‘In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.’_

**Knowledge, Skills, Abilities**:

- Detailed knowledge of **GCP** and appropriate regional research regulations and guidelines
- Proficiency in a conducting GxP audits
- Excellent oral and written communication skills
- Strong problem solving, critical thinking, risk assessment and impact analysis abilities
- Confirmed experience in root cause analysis
- Demonstrated organizational and time management skills
- Flexible and able to multi-task and prioritize complex demands/workload
- individuals with prior experience in Clinical Quality Assurance/Compliance - GCP audit, inspection, consultancy experience is necessary.
- Travel under 25%

**Our 4i Values**:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 Reasons To Work At Thermo Fisher Scientific | Thermo Fisher Scientific.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

**Careers at Thermo Fisher Scientific | Thermo Fisher Scientific jobs**: