GCP Auditor Compliance Manager

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 competing 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 under pressure while prioritizing and handling multiple projects or activities.
• May require travel, ~10%.