Manager, Clinical Quality Assurance

Overview

The Manager of Clinical Quality Assurance will play an important role in ensuring GCP compliance in support of Iovance’s clinical programs.

This position partners with other departments such as Clinical Operations, Clinical Data Management, Regulatory Affairs, Clinical Supply Chain and Logistics, Drug Safety and other teams in developing SOPs, conducting clinical audits and document reviews and supporting regulatory agency inspections.

Essential Functions and Responsibilities

• Assist with the development and management of the clinical QA audit program including audits of investigator sites and contract service providers to ensure GCP compliance.
• Plan and perform clinical GCP audits and GVP audits; issue audit reports and track responses to closure
• Manage external contract auditors as needed
• Ensure quality and compliance issues are addressed and CAPAs are tracked to completion while maintaining audit and CAPA logs and associated clinical QA documentation.
• Review clinical protocols, investigator brochures, reports and other documentation to ensure compliance with regulatory requirements.
• Develop and maintain Clinical Quality Assurance SOPs; contribute to the development of other related procedures (Clinical, Drug Safety, etc.).
• Assist with preparation of Quality Agreements as applicable
• Review and approve clinical documents and regulatory submission documents as needed.
• Support GCP QA regulatory Health Authority inspections such as the FDA and EMA, etc.
• Perform internal audits
• Generate quality metrics and advise management, as appropriate
• Participate in Quality Management Reviews and represent CQA in project teams
• Provide GCP training as needed
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethnics
• Perform miscellaneous duties as assigned

Travel

Some travel required (approximately 25%).

Required Education, Skills, and Knowledge

• BS in life sciences or equivalent experience
• Sound knowledge and understanding of global GCP regulations and guidance
• 8+ years overall QA or clinical experience with at least 2 years of direct and relevant clinical quality assurance experience (GCP)
• Knowledge of FDA GCPs, EMA Regulations and ICH guidelines
• Strong interpersonal, written and oral communication skills
• Ability to manage competing priorities
• Proficiency in the use of relevant computer systems including MS office

Preferred Education, Skills, and Knowledge

• Oncology experience is a plus
• Prior experience with regulatory inspections and inspection readiness is a plus

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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• 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 [email protected] .

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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