Senior Manager, GMP and QMS Quality Operations

Role Overview & Key Functions:

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…