Quality Control Compliance Supervisor

Overview

Iovance Biotherapeutics is a growing, late‐stage company focused on the development and
commercialization of novel cancer immunotherapies. Iovance is seeking a Supervisor, Quality Control
Compliance who will be responsible for the implementation and long‐term sustainability of investigation
closure within the Iovance Quality Control Department at iCTC. This role is responsible for identifying
and driving continuous improvement in collaboration with QC functional areas, and the creation of
programs to ensure TAT is met and records are closed on time. In addition, this role will provide
strategic planning for driving QC quality records, CAPAs, Change Control actions, audit observations and
responses are managed, tracked and closed on time. This position is responsible for maintaining driving
programs to meet Site Quality Metrics. The QC Compliance Supervisor must have experience in technical
writing, problem solving, different operational excellence concepts (Go See, Process Standardization),
tier governance, and be a highly collaborative team player who works well in dynamic environments.
The position will report to the Manager, Quality Control Compliance.

Essential Functions and Responsibilities

• This is a people management role with direct reports. Responsible for performance evaluations,
  mitigation of on‐the‐floor events, escalating events and problem solving.


• Manage deviation and laboratory investigation workload to ensure on time closure of records.


• Support change management for investigation improvements to support clinical and commercial
  manufacturing


• Ensure QC deviation tier management structure, triage meetings, deviation closure meetings,
  and represent QC at deviation review boards, as needed


• Contribute data to the sites KPIs, metrics, heat maps, and A3s to measure QC investigation
  performance.


• Utilize SME knowledge of MasterControl and investigations tools to collaborate with QC
  leadership to define strategy, plan, and oversee the execution of key initiatives that deliver
  significant business value.


• Support training and coaching of technical writing and root cause analysis.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)


• 1‐3 years of experience in the biopharmaceutical industry within a cGMP Quality Control role


• Basic knowledge of biological drug development with respect to Quality Control


• Extremely detail‐oriented with strong analytical, written, and verbal communication skills


• Demonstrate sense of urgency; ability to recognize time sensitivity


• Flexible and adaptable style with an eagerness to take on challenges


• Advanced problem‐solving skills are preferred.

Preferred Education, Skills, and Knowledge

• Experience with cell and/or gene therapy products


• GMP regulated laboratory experience


• Knowledge of investigation writing

The physical demands described here represent those that an employee must meet to perform the
essential functions of this job successfully. Reasonable accommodation may be made upon request to
enable individuals to perform essential functions. Please contact Human Resources to request
accommodation.

Physical Demands and Activities Required:

• Must be able to Sit for an extended amount of time in front of the computer or biological safety
  cabinet

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 position will work in both an office and a manufacturing lab setting.


• When in the lab, must be able to work in Lab setting with various chemical/biochemical
  exposures, including latex and bleach.


• Able to work in cleanroom with biohazards, human blood components, and chemicals.


• Potential exposure to noise and equipment hazards and strong odors.

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 equalopportunity
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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