(Senior) QA Compliance Manager, GCP/GxP

at  Thermo Fisher Scientific

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.
As a QA Compliance Manager/Senior Compliance Manager, you will conduct complex internal and external audits and process audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience in GCP area that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience. Previous experience in other GxP areas welcomed.

KNOWLEDGE, SKILLS AND ABILITIES:

• Thorough knowledge of GCP / GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency leading a range of project based or internal GCP/GxP audits and vendor audits to high standards
• Excellent oral and written communication skills
• Willingness to travel (up to 50%)
• Strong problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/workload
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

SUMMARIZED PURPOSE:

Conducts complex internal and external GCP internal and/or external audits and process audits verifying compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for internal process audits and contracted quality assurance audits., internal site audits, laboratory and file audits for clients and projects.

ESSENTIAL FUNCTIONS:

• Conducts and/or leads a variety of client, internal or GCP/GxP audits and process audits as requested by senior management
• Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit.
• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
• Serves as a resource to operational departments on audit or quality assurance subject matter
• Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
• Provides mentorship and guidance to junior auditors