Senior Clinical QA & CSP Oversight Specialist

Iovance Biotherapeutics, Inc.; United States; Hybrid; USD 110.000 - 120.000; Vollzeit

Zusammenfassung

Iovance Biotherapeutics, Inc. is seeking a Clinical QA Specialist II to oversee CSP qualification and CSP oversight in a global CQA program. The role focuses on ensuring CSPs meet GCP regulations and company standards, conducting risk-based assessments, and managing CSPCARs, CAPAs, and quality events.

The candidate should have strong organizational and communication skills, experience in CSP oversight, and the ability to work in a fast-paced, remote environment with cross-functional teams.

Qualifikationen

• 5+ years of GCP or QA experience including 2+ years in service provider oversight.
• Strong interpersonal, written and oral communication skills.
• Exceptional organizational and critical thinking skills.
• Ability to build partnerships and diplomatically work with other departments.
• Proficiency in MS Office and related computer systems.

Aufgaben

• Maintenance of the CSP qualification/requalification and oversight programs.
• Completion of CSP qualification/requalification activities for CSPs (CROs, laboratories, imaging services, ethics committees, computer systems/software, etc.).
• Risk identification and mitigation for CSPs.
• CQA perspective: manage quality events, non-compliances, CAPAs, and CSPCARs; negotiate quality agreements.
• Represent at study management team and CSP meetings.

Kenntnisse

GCP/QA experience

Service provider oversight

Interpersonal communication

Organizational skills

MS Office proficiency

Ausbildung

BS in life sciences

Tools

MS Office

Jobbeschreibung

Clinical QA Specialist II, Clinical Specialist Providers (CSP)

Remote

AboutIovanceBiotherapeutics, Inc.

Iovance Biotherapeutics , Inc.isthe global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors.Amtagvi® (lifileucel) is the firstFDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs inadditionalsolid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment,Iovanceoperates as an end-to-end cell therapy company, anchored by fully owned, centralizedU.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com .

Amtagvi® and its accompanying design marks,Proleukin ® ,Iovance ® , and IovanceCares™are trademarks and registered trademarks ofIovance Biotherapeutics, Inc.or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com .

Overview

Iovance is seeking a Clinical QA Specialist II, Clinical Specialist Providers (CSP) who has experience in clinical service provider (CSP) qualification and oversight in Pharmaceutical and/or Biotechnology companies.

The Clinical QA Specialist II, Clinical Specialist Providers (CSP) is an integral part of the global CQA function, supporting both Iovance teams and CSPs. This includes ensuring that CSPs are appropriately assessed/periodically reassessed using a risk based methodology to ensure that they are able to meet/continue to meet Iovance’s needs, assessing/mitigating the risks associated with the use of CSPs, and providing general oversight from a CQA perspective, including quality event review/assessment, quality agreement negotiation, implementation and management of CSP corrective action requests (CSPCARs). S/he will be an innovative individual who takes ownership of CSP oversight to ensure GCP compliance with country/regional regulations and guidelines as well as the company’s policies and procedures. The successful candidate will possess exceptional organizational, critical thinking, and task prioritization skills, be a resourceful individual who is passionate about working with others in complex, changing, and fast-paced environments.

Essential Functions and Responsibilities

• Maintenance of the CSP qualification/requalification and oversight programs
• Completion of service provider qualification/requalification activities for a variety of CSPs (CROs, laboratories, imaging services, ethics committees, computer systems/software, etc.)
• Risk identification and mitigation for CSPs
• Service provider oversight from a CQA perspective, including interventions when the service provider is not performing as required (manage quality events, non-compliances, CAPAs, serious breaches, CSPCARs, etc.), and quality agreement negotiations
• Provide representation at study management team and CSP meetings
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics

Travel

Some travel required (up to 20%).

Required Education, Skills, and Knowledge

• BS in life sciences or equivalent experience
• 5 + years of overall GCP or QA experience including 2 + years in service provider oversight
• Strong interpersonal, written and oral communication skills
• Exceptional organizational and critical thinking skills
• Must be able to build partnerships and diplomatically work with other departments
• Proficiency in the use of relevant computer systems including MS office

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, administration, critical thinking and task prioritization skills, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

This job operates in a remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

#li-onsite

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.

Pay Transparency

$110,000 - $120,000 USD

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 [e-mail] .

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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