Most Loved Workplace® Certified JobSenior Manager, GMP and QMS Quality Operations
Most Loved Workplace® Certified JobAbout the Role
At Karyopharm Therapeutics, a Most Loved Workplace® certified employer in the Biotechnology space, Pioneering cancer therapies through extraordinary science and patient-driven innovation..
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.
Want to learn more about what it's like to work at Karyopharm Therapeutics? View our full profile.
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
- Broad salary ranges to reflect market conditions and the specialized nature of our work
- Anticipated base salary range for this position is $150 K –$175 K USD
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Why This Is a Most Loved Workplace® Certified Job
Systemic Collaboration
Karyopharm is charting a bold path forward, cultivating innovation to achieve their mission of defeating cancer. Through relentless determination and a patient-centric focus, every employee throughout the organization plays a pivotal role in delivering life-changing therapies. By advancing an already strong pipeline, embracing new opportunities, and pushing the boundaries of what’s possible, they’re not just imagining a better future for patients—they are building it.
Positive Vision for the Future
Karyopharm employees are committed to operating by a set of values that help them challenge the status quo in pursuit of excellence. Their values, known as ICARE - Innovation, Courage, Alignment, Resilience, and Energy - shape a unified culture where they turn challenges into opportunities that will help them achieve their shared purpose of defeating cancer. These values also form the foundation their talent management, personal development, and rewards and recognition systems, which include celebrating achievement through ICARE Awards that recognize everyday acts of collaborations and accountability.
Alignment of Values
Richard Paulson, Karyopharm’s CEO, champions a culture of innovation and resiliency by driving bold decisions and focusing on employee engagement. Under Richard’s leadership, Karyopharm Therapeutics has successfully navigated inherent challenges of scaling a commercial-stage biotech organization, while maintaining an unwavering commitment to the development of new novel therapies to help patients. He is a visionary leader who sets clear goals, and genuinely cares about people. Richard empowers teams to deliver, aligns the organization, and unites employees in our shared mission to transform cancer care.
Respect
At Karyopharm, respect is at the foundation of how employees work together. They create and foster an environment where employees feel heard through open forums and programs that promote transparency, integrity, respect, and diversity of thought. Their performance reviews and development processes embrace the whole person, recognizing and valuing the differences and uniqueness of each employee. In addition, Karyopharm is committed to the Inclusion & Wellness of all employees – supporting employee resource groups to celebrate multicultural teams to ensure that respect and inclusion fuel our collective success.
Killer Outcomes
Karyopharm thrives on a profound sense of shared purpose. Our dynamic, cross-functional environment breaks down silos, fostering connections between teams and empowering them to innovate and adapt with agility. Every contribution is not only valued but actively encouraged, creating a culture where employees are equipped and inspired to take on complex challenges and deliver transformative solutions. Karyopharm Therapeutics size allows it to easily unite diverse perspectives and harness collective expertise, amplifying employees’ impact and accelerating progress toward achieving their mission.
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