POSITION LOCATION: Amsterdam
POSITION TITLE: Sr. Quality Assurance Specialist (FT/Limited Term)
POSITION REPORTS TO: Director, Quality Assurance
DEPARTMENT/UNIT NAME: Quality Assurance
The Senior Quality Assurance Specialist responsible for planning and execution of Quality Assurance deliverables while overseeing and evaluation the work performed by the department and providing mentoring to the Quality Assurance staff. This role requires advanced knowledge and experience in clinical quality assurance, global clinical research regulations, CAP and CLIA laboratory standards and industry standards in the conduct of clinical trial operations with a strong understanding of clinical research ethics and privacy.
AREAS OF RESPONSIBILITY:
Quality Assurance Implementation
Regulatory, Ethical Conduct, and Audit Monitoring
Expertise, Mentorship and Training
Applicants must have a minimum of an undergraduate degree preferably in a Science and Life Science field along with 8+ years of relevant experience. The successful candidate will possess a strong background in process improvement including establishing/maintaining Standard Operating Procedures (SOPs). Experience and knowledge of Good Clinical Practice (GCP), computer system validation and CAP/ CLIA are an asset. Must have excellent verbal and written communication skills along with an advanced level of attention to detail. Must also demonstrate strong interpersonal relationship, collaboration skills working within cross-functional teams and a passion for Quality. Successful candidates must exhibit enthusiasm, determination, and intuitiveness, and be organized and detail-oriented.
*Accommodations for job applicants with disabilities are available upon request.
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