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Job Description
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.
North America
Remote based role, but requires some travel
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.
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
Provides guidance and consultation and support to project teams and external clients a subject matter expert (SME) for regulations, GxP, and CRG SOPs
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
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
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.’
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 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.
Full Time
Durable Manufacturing
$91k-117k (estimate)
02/18/2024
05/01/2024
thermofisher.com
WALTHAM, MA
>50,000
1956
Public
MARC N CASPER
$10B - $50B
Durable Manufacturing
Thermo Fisher is a life science research institution focused on providing laboratory equipment, chemicals, supplies and services.
The job skills required for Compliance Manager include Regulatory Compliance, Initiative, Problem Solving, Written Communication, Risk Assessment, Integrity, etc. Having related job skills and expertise will give you an advantage when applying to be a Compliance Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Compliance Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Compliance Manager positions, which can be used as a reference in future career path planning. As a Compliance Manager, it can be promoted into senior positions as a Compliance Manager, Senior that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Compliance Manager. You can explore the career advancement for a Compliance Manager below and select your interested title to get hiring information.