Specialist, Quality Assurance Compliance

Overview

Iovance is seeking a Specialist, Quality Assurance (QA) Compliance with experience in in the Pharmaceutical / Biotechnology industry.

This individual will be responsible for Quality System and Compliance activities to ensure GXP compliance in accordance with local and country regulations and guidelines, as well company policies and procedures. The selected team member should be innovative, energetic, collaborative, express a strong desire to learn and take ownership and accountability for Quality.

The Specialist will support and oversee Quality Compliance activities including, but not limited to: ensuring that Iovance facilities and staff are inspection/audit ready at all times, ensuring and supporting Internal audits (L1, L2, & L3) have been scheduled and completed, and driving Quality System records such as CAPAs/ Change Controls, Deviations to closure, and related Quality Systems and Compliance task. The successful candidate will be a key member of an established team who is passionate about working with others in complex, changing, and fast-paced environments.

Essential Functions and Responsibilities

• Support Regulatory inspections and audit.


• Assist in Identifying and assigning individuals for inspection/audit team roles.


• Assist in projects that support inspection/audit readiness for which significant changes/improvements to business processes are expected.


• Participate in preparation activities related to regulatory inspections at company facilities, CMOs, and suppliers/vendors.


• Ensure effective and timely Quality support of commitments to corporate timelines, milestones, and regulatory requirements.


• Support the management of the Iovance Internal Compliance Framework from a policy aspect and assist internal self-inspections, Level 2 and, act as a quality contact for Level 3 internal audits.

Required Education, Skills and Knowledge

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 2+ year relevant experience 


• Current and working knowledge of United States Code of Federal Regulations, ICH Guidelines, EU, ISO, and/or other local government regulatory requirements


• Working knowledge of MasterControl or other programs such as TrackWise, Veeva, or other related eQMS programs preferred, but not required.


• Working knowledge of data integrity principles (21 CFR Part 11/ Annex 11)


• External and/or internal audit experience preferred, but not required


• Experience reviewing quality agreements or contract preferred, but not required


• Proven ability to manage multiple projects while maintaining quality


• Proficient oral and written communication skills


• Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally


• 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 an 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 works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. 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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