Manager, Quality Assurance Operations - Swing Shift

Overview

The Manager Quality Assurance (QA) IOVAA QA Ops is responsible for supporting daytoday 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 onsite and will manage the internal QA Operations team. The Manager is an

effective communicator and is comfortable working in a complex and fastpaced environment.

Shift is MondayFriday 3:00PM11:30PM

Essential Functions and Responsibilities

Quality Assurance Operational Support:

Ensure that day today 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 inspections.

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.

Team Leadership:

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 staffed. Intervene where necessary to expedite decision making or to meet target timelines.
Fully trained in QA processes to enable handson 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 area. Significant quality assurance experience and
a thorough understanding of regulatory requirements for a cGMP facility is required.
Experience leading development initiatives i.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 skills. Strong technical writing ability required.
Proactive results oriented selfstarter 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 qualification.
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 problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

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 do not constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or change the positions responsibilities 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 individuals 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 .

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