Manager, Quality Control Training

Overview

The Manager of QC Training will provide leadership in the activity-based learning space within the Iovance
Cell Therapy Center (iCTC), IOVA-A, and Navy Yard Training Facility in Philadelphia, PA. This individual will
be directly responsible for maintaining and continually improving a formal training program for the quality
control department and, as necessary, collaborating with manufacturing and QA Training departments to
execute the training program. This is a people management role and is expected to lead training specialists
to manage the training program. As a highly effective “Lean Labs” and "Right First Time" program is
required for QC laboratories and supporting departments, a robust training program must be maintained
to ensure timely, efficient, and effective training of individuals. This role is responsible for developing,
conducting, and revising a QC training program on the methods used in the analytical and microbiology
laboratories (involving Flow cytometry, Environmental Monitoring, potency assays, etc.). This role will also
manage the training program for QC Supporting Departments like Investigations/Technical Writing, Raw
Materials testing, use of LIMS and other electronic system, at a minimum. This role is responsible for
defining and facilitating the collection of Quality Training KPIs and working with QCLT to ensure training is
completed in a timely manner.

Essential Functions and Responsibilities:

• Identify training needs, work with learning professionals and QC leadership to create an organizational
training strategy and curriculum. Oversee the implementation of the program.
• Evaluate effectiveness of training through competency testing and establish a communication loop to
ensure feedback is captured and implemented for training initiatives.
• Develop a training schedule, coordinate the staffing and scheduling of training for all QC groups.
• Ensure training documentation is maintained. Ensure training schedules meet company capacity planning
and quality targets.
• Establish curriculum design and support documentation, including drafting and approval of SOPs.
• Training and development of staff, including mentoring/coaching, and fostering a culture of continuous
improvement and operational excellence.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and
efficacy of training.
• Report on QC training metrics. Work with quality leadership to define and track key performance
indicators to measure training effectiveness.
• Ownership of QC Training Strategy, Training Curriculum and training assets to support QC methods and
processes and implementation of training across QC.
• Create processes that enable timely and actionable performance feedback of trainees.

Leadership:

• Manage a team of Training Specialists, providing guidance and support.
• Conduct performance evaluations and provide feedback for professional development.
• Foster a collaborative and positive team environment.
• Mentors new Training Specialists during onboarding/qualification process.

General:

• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Ensure efficient compliance with cGMPs and safety regulations including safety SOPs, SDS sheets, and
laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Required Qualifications: Education, Skills, Knowledge and Experience

• Minimum bachelor’s degree in biology, biochemistry, bioengineering, or related technical field, or
equivalent industry experience.
• Minimum of 8-10 years of experience in biopharmaceutical based GMP operations with a solid
understanding of the Quality function.
• Experience successfully working in a QC laboratory role/level
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) related to the QC
laboratory
• Proficiency in basic and advanced analytical methodologies within a functional laboratory
• Understanding and functional knowledge of QC Bioassays related to Flow Cytometry, Microbiology assays,
cell counts, and/or potency assays
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Experience managing quality training systems, as well as creating and implementing curricula.
• Well-versed in corporate learning theory including modern learning approaches and learning systems.
• Prior experience transforming basic ‘read and understand’ training into a capabilities and skills focused
training program.
• Experience with regulatory inspections
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Proficiency with Microsoft Office Suite (Outlook, Excel, Word, and PowerPoint)
• Requires ability and flexibility to work or support multiple shifts and provide occasional support on the
weekends, as needed.
• Ability to work successfully in a fast-paced matrix environment.
• Excellent oral and written communication skills and ability to work with internal and external stakeholders.
• Strong Project Management skills combined with a structured and solution‐oriented work approach
• Lean Practitioner and certified Green Belt preferred

Preferred Education, Skills, and Knowledge

• Experience working in Cell and/or Gene Therapy preferred.

The physical demands described here represent those that an employee must meet to perform the essential
functions of this job successfully. Reasonable accommodation 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 wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs,
gowning coverall, masks, gloves, etc.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

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 QC/manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including
latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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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