||Executive Director, GxP Quality Assurance & Compliance
Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical
program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced
Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Boston, MA with offices in Carlsbad, CA and across the EU and Canada.
GXP QUALITY ASSURANCE & COMPLIANCE
This position will report to the Head of Regulatory Affairs and will be the Akcea Quality Lead for ensuring current good practice regulations (GxP), including current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Pharmacovigilance
Practices (GVP), and Good Distribution Practices (GDPs, have been met throughout the development and commercial life cycle of Akcea products.
The successful candidate will be able to: (1) Define and drive the GxP Quality vision and mindset of the entire company (including the Akcea Ireland entity) in close collaboration with the executive leadership team; (2) Define clear Quality objectives and
ensure progress and cross-functional completion of responsibilities; use judgment to develop pragmatic solutions, and drive risk analysis and mitigation strategies; (3) Oversee all aspects of Quality related to the manufacture of development and commercial
drug substance and drug product; (4) Provide leadership, guidance, and direction to staff consistent with GxP regulatory and industry standards; (5) Support Supply Chain, Development Operations, Pharmacovigilance, Regulatory Affairs, IT, Medical Affairs, and
other functional management as they relate to quality operations.
- Develop and implement the long-term Quality strategy for the Akcea business model and provide overall quality oversight of outsourced vendor activities.
- Establish, implement, and maintain the GxP Quality Management System for Akcea’s internal needs and ensure GxP compliance to these systems
- Ensure Qualification and QA/C oversight of outsourced vendors involved in the development and commercial manufacturing, testing, packaging, labeling, storage, and distribution of drug substance and drug product, through all phases of product development.
- Maintain up-to-date knowledge of FDA, ICH, EU and other country specific regulations and guidelines.
- Ensure process validation activities for packaging and labeling.
- Ensure Cold chain shipping validation for drug substance and drug product before and after packaging for domestic and international shipping.
- Ensure the quality & compliance of Akcea’s manufacturing business practices and activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations.
- Ensure Akcea and outsourced vendor inspection readiness and serve as a key participant in regulatory inspections.
- Lead the Annual Product Review/Periodic Quality Review for commercial products.
- Maintain up-to-date knowledge of FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities.
- Oversee the Management of deviations/investigations, Out of Specifications, CAPAs, change control, product complaints, recall, and health hazard assessments in compliance with internal procedures.
- Oversee the Management of the Material Review Board to provide final disposition of Non-Conforming Materials.
- Oversee Product Release and approval for distribution for drug substances/products manufactured for clinical and commercial use.
- Oversee Maintenance of Design History Files and associated combination product documentation.
- Develop the annual Quality Plan. Manage deliverables to key milestones.
- Oversee GxP training program for relevant internal staff.
- Oversee full-time and contract staff who may be delegated to perform any of the activities listed above.
- Executes other duties as delegated.
For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.
||Send This Job to a Friend