Senior Manager, Quality Control Lean Labs & Strategic Planning

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  Iovance is seeking a Senior Manager, Quality Lean Labs and Strategic Planning who will be responsible for the implementation and long-term sustainability of the Lean Labs initiative within the Iovance Quality Control Department.  This role is responsible for identifying and driving continuous improvement in collaboration with QC functional areas, and the creation and maintenance of the QC workforce models to ensure patient demand is met.  In addition, this role will provide Strategic Planning for the implementation of pipeline products and projects in the QC department.  This position is responsible for maintaining knowledge of Lean Labs principles and various operational excellence strategies within the department by providing lean focused leadership, training, coaching, and mentorship to QC personnel.  The Senior Manager of QC Lean Labs & Strategic Planning must have experience with Lean Labs, different operational excellence concepts, tier governance, workforce modeling and planning, and be a highly collaborative team player who works well in dynamic environments.  The position will report to the Vice President, Quality Control.

Specific Responsibilities

• Drive deployment, hypercare, change management, and maintenance of ongoing Lean Labs implementation in Quality Control.
• Build and maintain QC workforce models.
• Ensure QC tier management structure is aligned with the overall Iovance tier governance program.
• Develop KPIs, metrics, heat maps, and A3s to measure performance of quality functional areas.
• Utilize SME knowledge of lean methodologies to collaborate with QC leadership to define strategy, plan, and oversee the execution of key initiatives that deliver significant business value.
• Develop QC’s lean capabilities by facilitating training and coaching of problem solving using the lean tool kit.
• Collaborate with other continuous improvement professionals to cascade needs and projects throughout the business and achieve solutions that drive positive business results.

Education and Qualifications

• 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 cell and/or gene therapy products is a plus
• Experience with different operational excellence concepts including (but not limited to) Lean Labs, lean practioner, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, change management, leader standard work.
• 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

Physical Requirements

• Sit for an extended amount of time in front of the computer

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, 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.

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