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Job Description

Conduct complex internal and external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations.

Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address issues.

Perform technical document review and other GxP practice activities in support of clinical development programs.

Provide audit reports to management.

Plan and deliver quality services including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.

Lead process/quality improvement initiatives.

Mentor junior staff.

Develop tools and other materials for tracking of compliance management activities and analyze trends.

Upon request, support regulatory inspections and/or client audit hosting.

Qualifications:

Education and Experience:

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

Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

• Thorough knowledge of applicable GCP GxP and appropriate regional regulations. Other GxP knowledge is a plus.

• Extensive knowledge of the clinical trial process

• Demonstrated proficiency and led a range of study-specific (site, eTMF, database, and Clinical Study Report) audits or other GxP audits, including process and vendor audits to high standards

• Solid experience in root cause analysis and CAPA development

• Expert knowledge of SOPs and WPDs

• Excellent oral and written communication skills in local and English language (including appropriate use of medical and scientific terminology)

• Proven training/mentoring experience of staff on a few process/topics

• Strong attention to detail

• Effectively works independently or in a team environment

• Highly developed problem-solving skills, risk assessment and impact analysis abilities

• Strong negotiation and conflict management skills

• Strong organizational and time management skills including ability to multitask and prioritize competing demands/workload

• Strong computer skills; ability to learn and become proficient with appropriate software

• Proven flexibility and adaptability

• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

The following are a plus:

• Experience auditing in the US and Canada.

• Experience hosting client audits and/or regulatory inspections.

Management Role:

No management responsibility

Working Conditions and Environment:

• Work is performed in an office/laboratory/clinical environment.

• Exposure to electrical office equipment.

• May require use of personal protective equipment required such as protective eyewear, garments, and gloves.

• Occasional drives to site/office locations with up to 50% travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.

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.