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Overview
Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Sr. Manager, Quality Control Compliance, who will be responsible for the implementation and long-term sustainability of investigation closure within the Iovance Quality Control Department at both iCTC and IOVA-A. This role is responsible for identifying and driving continuous improvement in collaboration with QC functional areas, and the creation of programs to ensure turn-around-time (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, tier governance, and be a highly collaborative team player who works well in dynamic environments. The position will report to the Director, Quality Control Compliance.
Essential Functions And Responsibilities
Drive change for Investigation Improvements to support commercial manufacturing.
Ensure QC deviation tier management structure, triage meetings, deviation closure meetings are aligned with the overall Iovance Investigation governance program.
Update site KPIs, metrics, heat maps, and lean six sigma techniques 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.
Facilitate training and coaching of technical writing and root cause analysis.
Resolve issues that are escalated by the investigation community.
Use Lean Labs initiatives to ensure ways of working are standardized, as required.
Ensure proper CAPAs are in place to support investigation root causes.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.
Required Education, Skills, And Knowledge
Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
Minimum (9) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
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 multi-disciplined teams in a global setting
Extremely detail-oriented 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
Preferred Education, Skills, And Knowledge
Experience with cell and/or gene therapy products
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 wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
Must meet requirements for and be able to wear a half-face respirator.
Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
Must be able to use near vision to view samples at close range
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to lift and carry objects weighing 45 pounds.
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 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 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 careers@iovance.com.
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Biotechnology Research
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