Overview

The Supervisor, Quality Assurance Operations is responsible for supporting day-to-day GMP QA Operations activities supporting manufacturing, testing and release of iPBMCs in a GTP and GMP compliant manner. The role will be collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The Supervisor will provide overall Quality Assurance support inclusive of but not limited to review and approval of room qualification protocols/reports, line clearance, ongoing environmental monitoring/ cleaning documentation, APV’s / PPQ’s, routine production, batch record review and release of iPBMCs. The successful candidate will support and manage the internal team and be on site.

Shift:

Tuesday – Friday 5pm – 3am

Essential Functions and Responsibilities

• Supervision and Development of direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
• Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.
• Develop a comprehensive understanding of current quality control processes, as this role is viewed as a subject matter expert within specific area. Significant quality laboratory experience and a thorough understanding of regulatory requirements for a cGMP Laboratory is required.
• Act as a subject matter expert (SME) and train new laboratory personnel.
• Support Health Authority inspections
• Perform review of documentation and logbooks for quality, completeness, and accuracy.
• Ability to work under limited supervision and to handle problems of a more difficult nature.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
• Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Ensure the department understands and complies with quality standards and requirements as documented.
• Ensure efficient operations, and compliance with cGMPs and safety regulations.
• Support thorough GMP investigations for out of specification test results and other quality events.
• Fully trained in laboratory processes to enable hands on assistance when necessary.

Required Education, Skills, and Knowledge

• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry and technical experience.
• Minimum of 5 years of experience in biopharmaceutical based GMP quality operations, including experience in cell culture.
• Minimum of 3 years in a Lead/Leadership/Supervisory Role is desired.
• Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture testing.
• Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation (batch records, deviations, etc.). Strong technical writing ability required.
• Experience leading “development” initiatives, i.e., training, coaching, learning initiatives.
• Ability to mentor and provide best practices to other members of the team. 
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to entire staff, with the ability to manage the teams within the laboratory environment. 
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. High level of ownership and accountability
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

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

• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 45 lbs.

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 position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s responsibilities 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.

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