Senior Manager, GMP and QMS
Karyopharm Therapeutics Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $150,000 - $175,000 per year
Job Level
About the role
- Provides strategic and operational support within GMP Quality and Quality Systems
- Leads training initiatives
- Provides vendors management support
- Drives process improvement
- Partners cross-functionally to support successful Quality operations
- Contributes to the continuous evolution of the CSV program, training management program, and strategy for improvement of cross-functional Quality Compliance
- Supports 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
- Serves as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances
- Facilitates root cause / A3 problem solving and partners with business partners on deviations/CAPAs (close on time, prove effectiveness)
- Drafts, revises, reviews, and/or approves controlled documents including Standard Operating Procedures
- Represents QA on cross-functional project teams and with external partners
- Identifies and anticipates trends in quality issues; collaborates with leadership team to implement quality initiatives
- Responsible for managing CSV oversite including planning and scheduling validation activities with external vendors
- Ensures business partners assess and approve change controls for commercial processes for assessment of lot disposition processes
- Identifies areas of improvement in training system performance, training process and overall training procedures
- Manages training KPIs
- Ensures business partners implement adequate training modules and learning activities
- Contributes to the development, maintenance, and continuous improvement of SOPs, work instructions, and templates
Requirements
- 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
Benefits
- comprehensive benefits (medical, dental, vision, 401(k), and more)
- equity
- potential to receive annual target bonuses
- culture of employee engagement, diversity, and inclusion
- competitive salary
- generous equity offerings (RSU’s at time of offer and annual awards)
- best in class medical (deducible paid by KPTI)
- dental
- vision
- disability
- life insurance
- parental leave
- matching 401k program (immediate vesting)
- ESPP
- tuition reimbursement
- wellness program with a monthly stipend
- generous PTO and holidays
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMPQuality Management SystemRoot Cause Analysisdata analyticsLEANDMAICSix Sigmaclinical product developmentcommercializationbatch record review
Soft Skills
communication skillscritical thinkingproblem-solvinginfluential leadershipnegotiationpartneringbuilding alignmenttraining managementprocess improvementcollaboration