Position: Senior GMP Auditor GMP Quality Assurance
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Senior GMP Auditor is responsible for leading the vendor management program for Karyopharm GMP Quality and for presenting the program during regulatory inspections. The individual is also responsible for planning, conducting, and closing vendor audits to assess Karyopharm’s CMOs level of compliance with GMP regulations, guidelines, internal procedures and best industry practices. This individual acts as primary contact point for all audit related communication with vendors.
- Develop GMP audit plan per Karyopharm internal procedures
- Execute internal and external audits according to approved audit schedule; negotiate audit date, prepare and send agenda to auditee
- Write audit report and observations letter, issue audit follow-up documents in timely manner
- Evaluate auditee’s responses, communicate on compliance issues and corrective action surrounding audits
- Make and document decision for supplier qualification status, estate critical findings to Sr. Management
- Write, revise and review procedures for the supplier management program
- Document audit observations and CAPAs in electronic system
- Maintain approved supplier list
- Drive closure of CAPA resulting from audits, as needed
- Participate in regulatory audits, PAI readiness audits and inspections as directed by QA Management
- Review supplier change notifications and work with stakeholders to determine impact to internal systems.
- Support Technical Quality Agreements management, write TQAs using internal template, and communicate with suppliers for comment resolution
- Participate in cross site projects, as needed
- Provides back-up for the QA department in selected areas, as needed
- Up to 50% travel, domestic and international (1-2 vendor audits per month)
- BS / MS in a scientific or engineering discipline
- 5 years experience in pharmaceutical / biotech industry within Quality Assurance executing audits
- Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.
- Knowledge of FDA and EU cGMP requirements
- Ability to write and revise documents.
- Ability to use judgment in situations for which there are no precedents.
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
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