Senior Manager, GMP and QMS

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🕒 February 23

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Karyopharm Therapeutics Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company dedicated to pioneering novel cancer therapies. Driven by a belief in the extraordinary strength and courage of cancer patients, the company focuses on scientific innovation to develop potentially life-changing treatments for cancers with high unmet medical needs. Karyopharm is at the forefront of Selective Inhibitor of Nuclear Export (SINE) technology, addressing fundamental mechanisms of oncogenesis through ongoing clinical trials for various types of tumors, including hematologic malignancies and solid tumors.

📋 Description

• 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