Position: Senior Specialist of Quality Assurance Operations
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.
- Provide quality oversight of all outsourced operations related to raw material, in-process, and finished good production activities, including warehousing and distribution.
- Review and evaluate Batch Production Records for API, Drug Product, Packaging and Labelling to ensure all approved procedures were followed and all specifications were met, proper version control and document integrity, including data generated by different functions, and accordingly approve the final disposition and release of finished product.
- Review and approve label proofs and packaging customer requests for clinical trials in domestic and international markets.
- Track non-compliance events that occur during production and testing, collaborate with CMOs and CTOs on investigations and support remediation, as required.
- Support CMO/CTO audits and follow-up on audit CAPAs
- Assure that source data and information used in regulatory submissions and validation activities is accurate and traceable.
- Support the Quality Management Review.
- Support quality systems, including deviations, change control, CAPA, and continuous improvement.
- Establish/maintain effective relationships with vendors.
- Ensure quality expectations are being met in the areas of Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and Good Documentation Practice.
- Participate and contribute to regular meetings held by the Quality organization, and represent Quality at cross-functional meetings and improvement initiatives.
- Partner with QC to review/approve manufacturing testing data as well as protocols and reports associated with stability, method validation and method transfer, as needed.
- B.S. in Life Sciences or related science degree (Chemistry, Biochemistry, etc.) required (an advanced degree in a related field is a plus)
- A minimum of 7 years of direct experience in QA and/or QC within the Pharmaceutical or Biotechnology industry in an operational QA role
- Experience with manufacturing including API, drug product and packaging/labeling batch record review
- Experience with data review for accuracy, completeness and compliance
- Experience with the CMC and Regulatory Filing requirements
- Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations
- Understanding of product process and development, from discovery to commercialization is a plus
- Experience with small molecules and oral dosage forms is a plus
- Knowledgeable in FDA cGMP regulations, EMA, MHRA, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
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