ThermoFisher Scientific
Principal Operational Process and Compliance Specialist
ThermoFisher Scientific, Wilmington, North Carolina, United States, 28412
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 PPD 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.
Summarized Purpose:
Manages complex process improvement initiatives, working cross-functionally to enhance compliance, efficiency, and risk mitigation. Serves as a key resource in quality system governance. Essential Functions:
Leads mid-to-large scale, complex process improvement projects across departments. Proactively conducts in-depth risk assessments and develops mitigation strategies for quality concerns. Establishes and maintains process governance frameworks to ensure consistency in quality and compliance practices. Analyzes trends and provides insights for process optimization and compliance improvement. Collaborates with senior leadership to align process improvements with business priorities. May act as a subject matter expert in an assigned area. Mentors less experienced team members providing guidance on best practices in quality and process management. Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred. Knowledge, Skills and Abilities:
Broad understanding of procedural documents Excellent understanding of process improvement practices Advanced investigative and analytical skills Strong negotiation skills Broad understanding of clinical management technology and systems, and strong computer skills Familiarity with the practices, processes, and requirements of clinical trials Strong judgment, decision making, escalation, and risk management skills Effective oral and written communication skills including the ability to communicate in English, both orally and in writing Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting Great attention to detail Broad understanding of regulatory guidelines and directives Excellent creative and critical thinking skills We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally include: A choice of national medical and dental plans, and a national vision plan A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA) Tax-advantaged savings and spending accounts and commuter benefits Employee assistance programs At least 120 hours paid time off (PTO). 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy. Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Manages complex process improvement initiatives, working cross-functionally to enhance compliance, efficiency, and risk mitigation. Serves as a key resource in quality system governance. Essential Functions:
Leads mid-to-large scale, complex process improvement projects across departments. Proactively conducts in-depth risk assessments and develops mitigation strategies for quality concerns. Establishes and maintains process governance frameworks to ensure consistency in quality and compliance practices. Analyzes trends and provides insights for process optimization and compliance improvement. Collaborates with senior leadership to align process improvements with business priorities. May act as a subject matter expert in an assigned area. Mentors less experienced team members providing guidance on best practices in quality and process management. Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred. Knowledge, Skills and Abilities:
Broad understanding of procedural documents Excellent understanding of process improvement practices Advanced investigative and analytical skills Strong negotiation skills Broad understanding of clinical management technology and systems, and strong computer skills Familiarity with the practices, processes, and requirements of clinical trials Strong judgment, decision making, escalation, and risk management skills Effective oral and written communication skills including the ability to communicate in English, both orally and in writing Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting Great attention to detail Broad understanding of regulatory guidelines and directives Excellent creative and critical thinking skills We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally include: A choice of national medical and dental plans, and a national vision plan A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA) Tax-advantaged savings and spending accounts and commuter benefits Employee assistance programs At least 120 hours paid time off (PTO). 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy. Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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