Manager, Quality Control, External Operations

Overview

The Manager quality Control, External Operations manages day-to-day quality control operations for developing and manufacturing clinical and commercial cell therapy programs. This role requires having a good understanding of Quality Control and applying practical knowledge of phase appropriate GMPs and regulatory requirements in the product development life cycle, including but not limited to lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. Experience working in a GMP-regulated environment, including knowledge of health authority expectations for novel and complex oncology programs, is essential. All duties are performed with minimal supervision and oversight.

Essential Functions and Responsibilities

• Manage day-to-day GMP QC CMO/CTL testing activities for lot release testing compliance to procedures and adherence to regulatory requirements, including activities at external sites.
• Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance.
• Establish positive working relationships with external partners and processes for performance management, including routine meetings, onsite visits, performance monitoring, Person in Plant (PiP) and issue notification.
• Coordinates all quality control-related activities concerning timelines and compliance to External sites.
• Support method harmonization across external testing sites with internal requirements.
• Facilitate thorough GMP investigations for out-of-specification test results and corrective actions for QC CMO/CTL testing.
• Support problem-solving for technical issues about GMP quality control, working alongside technical SMEs as needed.
• Support review validation protocols, reports, and test methods to ensure all methods are harmonized across internal and external testing labs.
• Author and review Change controls, Risk and gap assessments as needed
• Support the technical transfer, qualification, and validation of test methods for in-process materials, lot release, and/or stability, as needed.
• Support internal and external audits and regulatory inspections on-site if needed.
• Manage a team of External Quality Control Specialists. Will be responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve people issues without direct supervision.
• Operate consistently and efficiently, producing high-quality and accurate results in a fast-paced environment.
• Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor's Degree in a relevant scientific field with a minimum of 8 years of experience or 6 years of experience and a master's degree.
• Relevant experience in a cGMP QC environment
• Experience with Cell and Gene Therapy products, relevant test methods, and CMC aspects of regulatory filings
• Experience with analytical test method validation and transfers.
• Understanding of relevant cGMP, ICH, and other global regulatory guidance
• Strong oral written communication, and interpersonal interaction skills
• Strong organization and problem-solving skills
• Able to balance priorities while maintaining a high level of productivity and compliance standards.

Preferred Education, Skills, and Knowledge

• Experience with regulatory inspections is preferred.

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 operates in a professional or remote office environment and 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.

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