04 oct
|
Jobrapido
|
Caló des Moro
04 oct
Jobrapido
Caló des Moro
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Office
Join Us as a Clinical Compliance Manager - Make an Impact at the Forefront of Innovation
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The Clinical Compliance Manager is responsible for the assessment, management, and reporting of different kinds of audits. The ideal candidate will serve as a subject matter authority on audits handling and support other activities related to QA across the clinical development portfolio.
What You'll Do
- Conduct complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, general regulatory guidelines, and/or client contractual obligations.
- Identification of issues impacting the quality and/or integrity of clinical research programs, determination of root cause of non- conformance and development of strategies to address issues.
- Upon request performance of technical document review and other GxP practice activities in support of clinical development programs.
- Provision of audit reports to management.
- Planning and delivery of quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Leads process/quality improvement initiatives.
- Develops tools and other materials for tracking compliance management activities and analyzes trends.
- Mentors less experienced staff and serves as project lead for group projects. Creates formal networks with key contacts across the department
Education & Experience Requirements:
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
- 5+ years of clinical research experience,
with at least 2 years in Clinical Quality, GCP Compliance, or related role.
- Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations.
- Proven experience in CAPA, root cause analysis, and deviation management.
- Demonstrated ability to communicate complex compliance issues clearly and effectively.
- Comfortable working in a matrix organization and managing cross-functional customers.
- Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is a plus.
In some cases an equivalency, consisting of a combination 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:
- Thorough knowledge of applicable GxP and appropriate regional regulations
- Extensive knowledge of the clinical trial process
- Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
- Training/mentoring experience
- Strong attention to detail
- Effectively works independently or in a team environment
- Highly developed problem solving skills, risk assessment and impact analysis abilities
- Strong leadership skills
- Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load
- Strong digital literacy; ability to learn and become proficient with appropriate software
- Proven flexibility and adaptability
- Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Veeva QMS experience a plus
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. xugodme
Apply today to help us deliver tomorrow’s breakthroughs.
📌 Compliance Manager (Caló des Moro)
🏢 Jobrapido
📍 Caló des Moro