Manager, Quality Assurance Operations Philadelphia, Pennsylvania

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Iovance Biotherapeutics, Inc. is seeking a Manager, QA Operations to support day-to-day GMP QA activities for iPBMC manufacturing and release. The role leads the internal QA team on-site and communicates across functions to ensure compliant, timely results.

Ideal candidates have 8+ years in biopharma QA, 5+ years in leadership, and strong CFR/GMP knowledge, with a focus on continuous improvement and regulatory readiness.

Qualifikationen

• Minimum BA/BS in scientific or technical field.
• 8+ years in biopharma GMP quality operations.
• At least 5 years of lead/supervisory QA experience in manufacturing.
• Strong understanding of CFR 21 CFR 210/211 and related GMP practices.
• Excellent written and verbal communication and collaboration skills.
• Proven ability to train and mentor QA staff and drive improvements.

Aufgaben

• Oversee day-to-day QA Operations activities and lot disposition.
• Interact with CMOs and internal teams to enable timely batch release.
• Contribute to decisions based on QA principles and data.
• Identify and implement new approaches for efficiency and quality.
• Review and approve release documentation and investigations.
• Document standard work, SOPs, deviations, CAPAs, and changes.
• Support internal audits and regulatory inspections.

Kenntnisse

QA Leadership

GMP/cGMP Knowledge

QA Documentation

Regulatory Compliance

Mentoring / Training

Cross-functional Collaboration

Quality Systems

Problem Solving

Ausbildung

BA/BS in Biological/Physical/Chemical sciences, engineering, or related field

Tools

Electronic QMS

Microsoft Office

Document Control Software

Jobbeschreibung

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 ® , andIovanceCares™are trademarks and registered trademarks ofIovanceBiotherapeutics, 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

The Manager, Quality Assurance (QA), IOVA-A QA Ops is responsible for supporting day-to-day GMP QA Operations activities that support manufacturing, testing and release of iPBMCs in a GMP compliant manner. The individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The Manager provides overall Quality Assurance support including, but not limited to, review

and approval of qualification protocols/reports, validation protocols/report, batch record review and release of manufactured lots. The successful candidate will work on-site and will manage the internal QA Operations team. The Manager is an effective communicator and is comfortable working in a complex and fast-paced environment.

Essential Functions and Responsibilities

• Ensure that day -to-day activities for QA Operations and lot disposition are efficient, coordinated, and executed as planned.
• Ensure efficient operations, and compliance with quality standards, cGMPs, safety regulations, and requirements as documented.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
• Contribute to strategic and tactical decisions based on sound Quality principles and available data. Provide quality direction to, and gain alignment across, functions who are problem solving.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
• Perform review and approval of release documentation.
• Track and communicate standard work completion and hurdles upward and downward
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Support internal audits and regulatory inspection.

Subject Matter Expertise

• Act as a subject matter expert (SME) and train incoming staff
• Maintain comprehensive understanding of current quality assurance processes, as this role is viewed as a subject matter expert. Previous quality assurance experience and familiarity with regulatory requirements for a cGMP facility is required.
• Complete accurate, thorough, and timely review and approval of laboratory investigations, deviation investigations, method validations, change controls, and CAPAs.
• Ensure that Quality Records (e.g., deviations, laboratory investigations, CAPAs, change controls) are adequately written and closed in a timely manner.
• Supervision and Development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence
• Ensure that QA staff are adequately organized, supervised, and Intervene, where necessary, to expedite decision making or to meet target timelines.
• Fully trained in QA processes to enable hands-on assistance when necessary.
• Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
• Ability to work under limited supervision and to handle problems of a more difficult nature.

General

• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
• Proficiency in generation and monitoring of departmental performance metrics
• Ability to effectively manage multiple changing priorities involving aggressive timelines at a high level of productivity. High level of ownership and accountability.
• Experience with use of an electronic QMS
• Proficient with Microsoft Office Suite, Word, Excel, and Powerpoint
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
• Perform other duties as assigned.

Required Education, Skills, and Knowledge

• Minimum BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or related technical field from an accredited university or college
• Minimum of 8 years of experience in biopharmaceutical based GMP quality operations, including experience in cell culture.
• At least 5 years of Lead/Leadership/Supervisory experience in QA roles, preferably within a manufacturing facility.
• Comprehensive understanding of current quality assurance processes, as this role is viewed as a subject matter expert within specific Significant quality assurance experience and a thorough understanding of regulatory requirements for a cGMP facility is required.
• Experience leading “development” initiatives, e., training, coaching, learning initiatives
• Ability to mentor and provide best practices and support to all teams within the Quality Assurance department.
• Clear and effective collaboration, communication, listening and writing Strong technical writing ability required.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Quality mindset, working knowledge of Code of Federal Regulations 21 CFR 210/211 and standard GxP best practices and FDA regulations.

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.
• Must be able to perform cleanroom gowning and pass gowning
• 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.

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 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] .