Bachelor's degree in a relevant discipline (biological sciences or equivalent)
Minimum (5) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
Overview
Senior Quality Control Specialist, QC Operations Strategy will be responsible for planning and managing projects with minimal oversight, utilizing principles and methodologies from Lean, Six Sigma, and Project Management to drive continuous improvement for all QC functional areas, and the creation and maintenance of QC workforce models to ensure patient demand is met. T 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. This position is also 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 Quality Control Specialist, QC Operations Strategy 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.
Essential Functions and Responsibilities
Drive deployment, hypercare, change management, and maintenance of ongoing lean labs implementation in Quality Control.
Build and maintain QC workforce models.
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.
Collaborate with other continuous improvement professionals to cascade needs and projects throughout the business and achieve solutions that drive positive business results.
Collaborate closely with the Senior Manager, Quality Control, Operations Strategy as well as other QC functions to strategically plan future projects such as new product introduction, laboratory capacity planning, facility transfers and expansions, and other pipeline projects.
Develop and upkeep planning tools to allow for site growth within the quality control organization such as headcount capacity models for increased manufacturing capabilities and onboarding of new quality control assays, tests, and processes that contribute to the release of lots and materials.
Facilitate the deployment, hypercare, change management, and maintenance of new and ongoing lean labs implementation in Quality Control.
Collect and analyze data from QC workforce models to allow for opportunity identification, solution development, and sustainability.
Monitor and routinely evaluate KPIs, metrics, heat maps, and A3s to measure performance of quality functional areas.
Act as subject matter expert to QC's lean capabilities by facilitating training and coaching of problem solving using the lean tool kit.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
Bachelor's degree in a relevant discipline (biological sciences or equivalent)
Minimum (5) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
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