Overview
Iovance is seeking a Clinical Quality Assurance Associate II who will be responsible for remotely supporting Iovance’s GCP quality system. The Clinical Quality Assurance Specialist II will support GCP quality system activities including clinical quality events, deviations, CAPAs, supplier corrective action requests, investigator site audits, service provider audits, internal audits, clinical change controls and regulatory inspections. The successful candidate will be growth-oriented, have a continuous improvement mindset, and will be someone who is passionate about working with others in a complex, changing, and fast-paced remote environment.
Essential Functions and Responsibilities
- Support the GCP quality system with emphasis on tracking clinical quality events, deviations, CAPAs, supplier corrective action requests, and change controls.
- Assist with the conduct and tracking of investigator site, service provider and internal audits.
- Maintain the GCP QMS.
- Identify opportunities to increase the efficiency and effectiveness of the GCP QMS.
- Represent Clinical Quality Assurance in cross-functional projects, where applicable such as system improvements and records management.
- Support regulatory inspections (e.g. prep room participant, runner, etc.)
- Support training activities and back-up efforts for clinical quality assurance processes.
- Maintain updated knowledge and relevant assessments of the GXP landscape, regulations, and guidelines pertaining to GCP quality assurance.
Travel
- Some travel required (approximately 10%).
Required Education, Skills, and Knowledge
- BA/BS or equivalent in life science from an accredited university or college with 2+ years of relevant experience
- Current and working knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Clinical Practices
- Experience with an electronic QMS, MasterControl preferred
Preferred Education, Skills, and Knowledge
- Oncology experience is a plus.
- Prior experience with regulatory inspections and inspection readiness is a plus.
- Must be comfortable in a fast-paced environment with minimal direction and changing priorities.
- Strong interpersonal skills and ability to work collaboratively across functions.
- Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal- opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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