GCP Auditor Compliance Manager

Thermo Fisher Scientific; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

At Thermo Fisher Scientific, as a QA Auditor/Compliance Manager, you will oversee quality control and regulatory compliance in clinical trials. You will lead audits and investigations to ensure adherence to GCP, support internal teams, and drive quality improvement initiatives, contributing to the mission of enhancing health outcomes globally.

Benefits

Competitive remuneration

Annual incentive plan bonus

Healthcare benefits

Career development opportunities

Qualifications

• Bachelor's degree or equivalent required.
• 2+ years of QA experience including GCP auditing.
• Strong knowledge of GCP and regulations.

Responsibilities

• Lead investigations into quality issues.
• Conduct audits and manage GCP regulatory inspections.
• Provide consultancy and mentorship to project teams.

Skills

GCP Knowledge

Problem Solving

Communication Skills

Critical Thinking

Root Cause Analysis

Education

Bachelor's degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 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.

Discover Impactful Work:

As QA Auditor/Compliance Manager, you will oversee quality by leading investigations into significant quality issues, supporting client audits and regulatory authority inspections, and providing consultancy to project teams within this highly visible team that touches many different aspects of quality.

A day in the Life:

• Serves as a primary contact for consulting to internal teams on issues of GCP and regulatory compliance, procedural document compliance; risk identification and mitigation; quality events reporting and management.

• Leads investigations into incidents of suspected scientific misconduct.

• Participates in identification, assessment, action planning and reporting of serious breaches of GCP and protocol.

• Conducts inspection preparation activities and provides training to investigator site and project team personnel.

• Conducts directed site audits and pre-inspection site preparation visits (minimal travel)

• Manages, supports, and reports on the outcomes of GCP regulatory inspections of investigator sites, clients, and Thermo Fisher Scientific.

• Collaborates with investigator site staff and clients on development and/or review of responses to regulatory authority inspection findings.

• Leads and/or participates in process/quality improvement initiatives.

• Provides mentorship and guidance to junior auditors as appropriate.

Keys to Success:Education

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

Experience

• Previous QA experience (including GCP auditing) that provides the knowledge, skills, and abilities to perform the job (2 years’ or more) or equivalent combination of education, training, & experience.

Knowledge, Skills, Abilities

• Thorough knowledge of GCP and appropriate regional regulations and guidelines

• Working knowledge of procedural documents

• Strong oral and written communication skills (English)

• Good problem solving, critical thinking, risk assessment and impact analysis abilities

• Able to work independently or in a team environment

• Solid experience in root cause analysis

• Flexible and able to multi-task and prioritize challenging demands/workload

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work independently or in a team environment
• Able to perform successfully while prioritizing and handling multiple projects or activities.
• May require travel, 10%.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!