We are hiring !

We are hosting an onsite Job Fair at :

 Iovance Cell Therapy Center (iCTC)

Thursday, March 21

12pm to 6pm (ET)

300 Rouse Blvd

Philadelphia, PA 19112

See you at the Job Fair 

Overview

Iovance is seeking a Senior 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 Senior 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.

This is a Hybrid position.

Specific Responsibilities

• Support Regulatory inspections and audits
• Provide inspection/audit readiness training.
• Assist in Identifying and assigning individuals for inspection/audit team roles.
• Assist in leading 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 Audit Program
• Support the management of the Iovance Internal Compliance Framework from a policy aspect and executing internal self-inspections, Level 2 and, act as a quality contact for Level 3 internal audits.
• Support Quality Continuous Improvement
• Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality improvements.
• Facilitate and/or support continuous improvement initiatives.
• Identify compliance gaps and lead focused teams to resolve compliance issues.
• Author or revise SOPs for continuous improvement of the company’s QA compliance.
• Establish and track quality metrics for applicable processes and present improvement opportunities for Quality Management Review
• Provide training and guidance on compliance topics to build quality mindset.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics and comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Provide guidance to colleagues.
• Perform miscellaneous duties as assigned.

Education and Qualifications

• A minimum of 8 years Biotechnology industry experience; cell and gene therapy experience preferred.
• Bachelor’s degree in scientific discipline
• Knowledge and application of global GMP regulations including but not limited to 21 CFR Part 11, 210, 211, 600, 820, 1271; EudraLex Volume 4; ISO 9001, 13485; ICH, other guidance.
• Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally
• Experience in preparing for and participating in regulatory inspections 
• Proven ability to manage multiple projects while maintaining quality
• Ability to meet deadlines and multi-task efficiently
• Must be comfortable in a fast-paced environment with minimal direction and changing priorities
• Experience identifying changes, driving improvements, and streamlining processes required
• Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

Physical Requirements

• Sit for an extended amount of time in front of the computer

• Extended periods of standing, walking, crouching, and sitting if supporting audit related activities

Travel Requirements

• None

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