Quality Assurance Specialist, Operations Strategy

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

Salary:

Company Overview

Iovance Biotherapeutics is a dynamic, late-stage organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. We are currently in search of a Quality Control Specialist focused on Operations Strategy, who will play a pivotal role in ensuring the long-term success of the Lean Labs initiative within our Quality Control Department.

This position will be instrumental in identifying and promoting continuous improvement efforts in collaboration with various QC functional areas. The Specialist will also be responsible for the development and maintenance of QC workforce models to meet patient demand effectively. Furthermore, this role will assist in strategic planning for the integration of pipeline products and projects within the QC department.

Key Responsibilities

  • Work closely with the Senior Manager of Quality Control, Operations Strategy, and other QC functions to strategically plan future initiatives, including new product introductions, laboratory capacity planning, facility transfers, and expansions.
  • Develop and maintain planning tools to facilitate growth within the quality control organization, including headcount capacity models for enhanced manufacturing capabilities and onboarding of new quality control assays and processes.
  • Support the deployment, hypercare, change management, and ongoing maintenance of Lean Labs implementation within Quality Control.
  • Maintain and update QC workforce models regularly.
  • Monitor and evaluate KPIs, metrics, heat maps, and A3s to assess the performance of quality functional areas.
  • Assist in enhancing QC's lean capabilities by facilitating training and coaching in problem-solving techniques using the lean toolkit.
  • Collaborate with other continuous improvement professionals to communicate needs and projects throughout the organization, achieving solutions that drive positive business outcomes.
  • Adhere to Iovance Biotherapeutics' core values, policies, procedures, and ethical standards.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures as per company policy and OSHA regulations.
  • Perform additional duties as assigned.

Required Qualifications

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • Preferred three years of experience in the biopharmaceutical industry within a cGMP Quality Control role.
  • Experience with various operational excellence concepts, including lean labs, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, and change management.
  • Fundamental knowledge of Quality Control operational and laboratory practices, including microbiology, analytical testing, sample management, quality records, and training.
  • Advanced proficiency in MS Office applications (Word, Excel, PowerPoint, Visio).
  • Ability to effectively collaborate with multi-disciplinary teams.
  • Detail-oriented with strong written and verbal communication skills.
  • Capacity to manage multiple priorities with aggressive timelines while maintaining high productivity.
  • Advanced skills in strategic planning and implementation.
  • Demonstrated sense of urgency and ability to recognize time-sensitive tasks.
  • Flexible and adaptable with a willingness to tackle challenges.
  • Proactive problem solver who identifies issues and leads resolution efforts.

Preferred Qualifications

  • Experience with cell therapy products is advantageous.

Physical and Mental Demands

  • Must be able to sit for extended periods while working on a computer.
  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; handle multiple priorities simultaneously; and meet deadlines.

Work Environment

  • This position will primarily work in an office setting, with occasional visits to Quality Control labs.
  • When in the lab, must be able to work in an environment with various chemical and biochemical exposures.
  • Able to work in cleanroom conditions with biohazards and chemicals.
  • Potential exposure to noise, equipment hazards, and strong odors.

Iovance is committed to fostering a diverse and inclusive workplace. We are an equal-opportunity employer, and all employees and applicants will be considered without regard to 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, or any other characteristic protected by applicable law.

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