Manages and leads all aspects of audits / audit conduct and QMS activities:
Provides leadership and guidance to other personnel as directed by their manager
Plans, conducts, and reports audits according to Bioclinica's standard operating procedures (SOPs) and electronic document management system (EDMS) processes.
Tracks and/or trends audit issues and/or CAPAs until closure.
Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned.
Champions timely management of quality event reports, audit findings, and CAPAs.
Follows-up and verifies effectiveness checks
Reports metrics to her/his manager and Bioclinica management as required.
Ability to work with all levels of Bioclinica personnel and external personnel in a professional and organized manner.
Identifies and implements process improvements, with a focus on the audit program.
Support the tracking and trending of all compliance reports and audit activities.
Communicating effectively, verbally and in writing, with all internal and external clients
Escalating quality concerns and problems to the Manager, Quality and Regulatory Compliance or designee(s)
Performing QA review of source documents, case report forms (CRFs), and other reports for accuracy
Working directly with Bioclinica development teams to ensure the accuracy and consistency of system development and validation deliverables.
Supporting/conducting/leading external (vendor/supplier) quality audits and hosts/leads Sponsor/customer audits
Facilitate quality training of peers on quality related matters
Secondary Responsibilities
Maintains Quality Service and Departmental Standards by
Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
Assisting in establishing and enforcing departmental and regulatory standards
Developing or revising SOPs
Contributes to team effort by
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Helping others to achieve results
Performing other duties as assigned
Maintains Technical and Industry Knowledge by
Attending and participating in applicable industry or company-sponsored training(s)
Qualifications:
Education:
Associate's degree or equivalent required, preferably in life sciences, clinical trials, quality management, or computer science
Quality and/or quality systems certification (e.g. ASQ Auditor, auditor training), or equivalent
Experience:
Approximately: 5 +years relevant experience in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries-preferably in Pharmaceutical, CRO, Biotech, Medical device
Demonstrated ability and track-record for leadership activities, supporting or mentoring personnel.
Possesses a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, Software Validation requirements and is competent with quality management systems (QMS)
Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations
Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
Understanding of medical and/or clinical trial terminology is desirable
Additional skill set:
Ability to work independently and/or across cross-functional teams; ability to adjust to changing priorities
Demonstrated ability to interact professionally and with confidence at all levels of internal and external personnel
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to manage multiple tasks effectively & efficiently
Proficient at problem-solving
Goal oriented
Ability to project and maintain a professional and positive attitude
Possess high-level ethics and integrity
The above qualifications will either be satisfied upon hire or through mentorship and oversight by a qualified Quality Assurance team member.
Working conditions:
Travel: 0-10%
Lifting: 0-25 lbs
Other: Computer work for long periods of time
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
