Offer summary

Qualifications:

BA/BS in Biological/Physical/Chemical sciences or engineering with 10+ years of GMP experience., 5 years of GxP audit experience and Audit Certification/CQA required., Current knowledge of US and international regulatory requirements including 21CFR and ISO standards., Strong interpersonal skills and proficiency in MS Office and eQMS programs..

Key responsabilities:

Lead and support QA Compliance with GxP audits for suppliers and internal audits.

Review and execute supplier quality agreements and assist with inspection readiness activities.

Review and approve change controls, deviations, and ensure timely closure of quality records.

Implement and maintain procedures based on compliance requirements and best practices.

Job description

Overview

Iovance is seeking an Auditor, QA Compliance who has experience in Quality Systems and Compliance in Pharmaceutical and/or Biotechnology companies.

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

The Auditor will support and oversee Quality Assurance activities including Quality Systems, primarily conducting supplier audits, supporting internal audits, reviewing change controls, product quality complaints, temperature excursions and quality agreements. The successful candidate will be a key team member of a well-established organization who is passionate about working with others in complex, changing, and fast-paced environments.

Specific Responsibilities

Independently lead and/or support QA Compliance with GxP audits, for contracted suppliers and internal audits. Responsibilities include the planning, coordination, and timely reporting
Review, revise, coordinate, and execute supplier quality agreements
Support and assist with commercial inspections, inspection readiness activities and other related activities as needed
Assist in the review and approval of change controls, deviations, CAPAs, supplier corrective actions requests (SCAR), product quality complaints, temperature excursions and ensure timely closures of records
Implement, enhance, and maintain procedures and work instructions based on best practices or compliance requirements
Maintain a continuous process improvement initiative mindset in all areas of work
Represent the Quality System and Compliance group in cross-functional projects where applicable

Education and Qualifications

BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 10+ years GMP relevant experience in an on-the-job decision-making role
Current and working knowledge of United States Code of Federal Regulations, ICH Guidelines, EU, ISO, and/or other global/local government regulatory requirements
5 years of GxP audit experience
Audit Certification/ CQA required with experience working in regulated environments specific to 21CFR Part 210/211, 600s, 1271, ISO 9001, ISO 13485, ISO 17025, etc.
Proven ability to manage multiple projects while maintaining quality
Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally
Working knowledge of MasterControl or other programs such as TrackWise, Veeva, or other related eQMS programs
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

Physical Requirements

Extended periods of standing, walking, crouching, and sitting when conducting audit related activities

Travel Requirements

Up to 35% domestic travel

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