Supervisor Quality Control Compliance
Supervisor Quality Control Compliance
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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 Senior Manager Quality Control Compliance who will be responsible for the implementation and longterm sustainability of investigation closure within the Iovance Quality Control Department at both iCTC and IOVAA. 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 Senior Manager of QC Compliance 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.
Essential Functions and Responsibilities:
- Manage deviation and laboratory investigation workload at IOVAA site to ensure on time closure of records.
- Support change for Investigation Improvements to support commercial manufacturing
- Ensure QC deviation tier management structure triage meetings deviation closure meetings carried out at IOVAA
- 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.
Education and Qualifications:
- Bachelors degree in a relevant discipline (biological sciences or equivalent)
- Minimum four 4 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
- Experience with cell and/or gene therapy products is a plus.
- Prior supervisory experience is a plus.
- Experience with different types of Quality Control investigations (OOT OOS Deviations Trend Investigations etc)
- Fundamental knowledge of Quality Control operational and laboratory practices including but not limited to microbiology analytical testing sample management quality records and training.
- Advanced proficiency in MS Office (Word Excel Powerpoint Visio)
- Successfully interface with multidisciplined teams in a global setting
- Extremely detailoriented with strong written and verbal communication skills
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
- Advanced strategic planning and implementation
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
- Problem solver who not only identifies issues but leads efforts to resolve them
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 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 deadline
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 our Candidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Full-Time
