Summary: The Manager of GMP and QMS Quality Operations provides strategic and operational support within GMP Quality and Quality Systems. This is a dynamic role that will be responsible for leading training initiatives, providing vendors management support, driving process improvement, and partnering cross-functionally to support successful Quality operations. The Manager contributes to the continuous evolution of the CSV program, training management program, and strategy for improvement of cross-functional Quality Compliance.

Key Responsibilities:

Reporting to the Executive Director, GMP and QMS Quality Assurance

GMP and QMS Quality Operational Support

• When applicable, support day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches
• Monitors operational activities and assesses continuous improvement within the QA operations
•  Serve as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances
• Facilitate root cause / A3 problem solving and partner with business partners on deviations/CAPAs (close on time, prove effectiveness)
• Draft, revise, review, and/or approve controlled documents including Standard Operating Procedures
• Represent QA on cross-functional project teams and with external partners
• Identify and anticipate trends in quality issues; collaborate with leadership team to implement quality initiatives
• Responsible for managing CSV oversite including planning and scheduling validation activities with our external vendors.
• Ensures business partners assess and approve change controls for commercial processes for assessment of lot disposition processes
• Supports additional work if/as directed by QA leadership

People Training & Development

• Leading training initiatives
• Responsible for training compliance oversite
• Identify areas of improvement in training system performance, training process and overall training procedures
• Manages training KPIs
• Ensure business partners implement adequate training modules and learning activities

Quality Project Oversite

• Remodel of the training management program
• Audit management and oversite processes
• Veeva enhancement initiatives
• Launch and sustain quality management with clear KPIs, short action logs, and escalations

Process Improvement & Documentation

• Identify inefficiencies, risks, and opportunities for improvement in Quality workflows.
• Contribute to the development, maintenance, and continuous improvement of SOPs, work instructions, and templates.
• Proactively identify trends/gaps/risks and implement plans to mitigate such trends/gaps and risks
• Participate in cross-functional initiatives and departmental process improvement efforts.

• Qualifications:

  • Bachelor's degree in life science or related discipline
  • Competence in GMP and Quality Management System requirements with at least 7-10 years of experience in QA, QMS, QC or Manufacturing in an FDA-regulated industry, preferably biologic therapeutics
  • In depth experience in all stages of clinical product development to commercialization product life cycle management
  • Direct experience with regulators (e.g., BLA, MAA submissions and/or inspections)
  • Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
  • Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
  • Ability to apply critical thinking and problem-solving skills to decision making and operational priorities
  • Demonstrated influential leadership experience operating in a matrix organization through presenting, influencing, negotiation and partnering is required
  • Capable of building alignment across diverse perspectives and functional areas
  • Able to demonstrate proficiency in Veeva Quality Suite
  • Excellent verbal and written communication

At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $150 K –$175 K USD.