Quality Control Compliance Supervisor
Quality Control Compliance Supervisor
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Overview
Iovance Biotherapeutics is a growing latestage 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 longterm 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 onthefloor 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 of key initiatives that deliver
significant business value. - Support training and coaching of technical writing and root cause analysis.
Required Education Skills and Knowledge
- Bachelors degree in a relevant discipline (biological sciences or equivalent)
- 13 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 detailoriented 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 problemsolving 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 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 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 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 .
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 ourCandidate Privacy Notice.
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Required Experience:
Manager
Employment Type
Full-Time
