Website Karyopharm Therapeutics Inc.
Karyopharm Therapeutics Inc.
Company : Karyopharm Therapeutics Inc.
Role Overview & Key Functions::
The Senior Director of Quality Assurance will provide strategic and operational leadership for the quality
oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution and
support Quality Management Systems within GMP operations . Manage activities and projects to meet
company objectives including review, approval and Quality oversight of all aspects of commercial
manufacturing at CDMOs, packaging and labeling, warehousing and the global distribution of commercial
API and Drug Product. Responsible for ensuring all company, regional, and global standards and regulations
are met, and that the department is developed and maintained to a standard that ensures the quality of
products and materials produced by our contracted partners
RESPONSIBILITIES:
- Strategic leader on the Quality and Compliance Leadership Team to represent the oversight and management of the GMP Quality team to support clinical and commercial manufacturing and supply.
- Provide oversight to and actively manage the GMP Quality Operations team.
- Provide expertise in GMP compliance interpretation, consultation, training, and recommendations.
- Collaborates cross-functionally other functions, such as CMC, Regulatory, Quality Systems, Vendor Management as needed to ensure alignment and best practices.
- Lead the team by planning and developing and attracting talent and ensuring that the team’s capabilities meet Karyopharm’s core value and future needs.
- Support development opportunities and mentor and coach team members.
- Lead and oversee writing/revising Quality SOP’s and performing review and approval of external and internal generated documents/reports (Master Batch Records, Executed BR’s, specifications, methods, validation documents, and other GXP Documentation).
- Lead implementation of a robust Vendor Oversight Program for GMP Quality Vendors.
- Ensure generation and maintenance of Quality Technical Agreements with Contract Service Providers.
- Lead and provide oversight of GMP team and facilitate development opportunities and mentor and coach QA team members.
- Lead and provide oversight the risk based GMP audit and compliance strategy. Lead the assessment of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
- Lead investigations into significant quality issues with focus on product impact and patient safety; escalate and manager MRB (Material Review Board) meetings; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
- Lead and oversee the GMP Quality Management Reviews (QMRs) as SME to GMP Quality Metrics. Analyze, report, and present metrics to functional teams and Quality management; Identify any risks and recommend any required actions and monitor implementation of mitigation or preventive actions.
- Lead identification and mitigation of GMP activities and process improvement initiatives.
- Collaborate with the GxP Quality team to ensure alignment and compliance with Karyopharm’s Quality Systems and other GxP functions.
- Must be able to articulate complex issues clearly verbally and written.
- Author, review, and/or approval documents including deviations, SOPs, and protocols.
- Demonstrated experience leading and hosting GMP audits, including health authority inspections.
- Lead and provide oversight on all Global Partnership/Alliance projects.
Candidate Profile & Requirements::
- Extensive (minimum 15 years) experience in GMP Quality Operations in Pharma/Biotech Industry, quality management, quality assurance or compliance roles with a focus on GMP.
- In-depth knowledge of other international regulations and guidelines related to GMP projects
- Excellent understanding of the drug development and commercialization process.
- Proven track record of successful management of quality management, quality assurance and/or compliance programs, including participation in audits and/or inspections, and investigating and addressing non-compliance issues.
- Demonstrated leadership skills and experience in managing cross-functional matrixed teams.
- Strong communication and interpersonal skills, capable of effectively collaborating with cross-functional teams and external stakeholders.
- Strong problem-solving and decision-making abilities, with a focus on continuous improvement.
- Experience in leading inspection readiness exercises and supporting health authority inspections is preferred.
- Minimum: BA/BS degree or in a life science discipline. Advanced degree is strongly preferred.
- Relevant certifications are desirable but not mandatory.
- Experience with small molecules is highly preferred.
- Experience in managing, hosting, or supporting FDA, EMA or other regulatory agency inspections
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 $240 K –$265 K USD.
Our Value Proposition::
At Karyopharm, we live and demonstrate our ICARE values every day!
If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission.
Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.
What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.
Check out our Culture Video!
What We Offer:
In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.
- A culture of employee engagement, diversity, and inclusion
- Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
- Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
- Wellness Program with a monthly stipend.
- Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
- Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
- Cell phone allowance