||Sr. Manager, 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 Executive Director of Quality and will be responsible for supporting and 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: ensure quality and compliance of Akcea-sponsored outsourced manufacturing activities and internal compliance to Akcea Standard Operating Procedures, applicable Regulatory requirements (FDA, EU, ICH & country specific),
and current industry standards and practices) have been met throughout the development and commercial life cycle of Akcea products, under the guidance of the Executive Director of Quality.
- Support the establishment, implementation, and maintenance of the GxP Quality Management System for Akcea's internal needs and ensure GxP compliance to these systems
- Support Qualifications 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
- Develop and implement Quality Agreements with outsourced vendors.
- Manage and oversee execution of the internal and external audit programs.
- Coordinate, schedule, prepare for, and conduct or oversee vendor and internal audits in accordance with established GMP QA/C goals and objectives.
- Draft and submit vendor and internal audit reports to relevant functions for review and input and communicate audit results to Management and stakeholders.
- Support process validation activities for packaging and labeling
- Support Cold chain shipping validation for drug substance and drug product before and after packaging for domestic and international shipping.
- Support process improvement activities as a subject matter expert (SME) in GxP.
- Assist in Akcea and outsourced vendor inspection readiness activities and serve as a key participant in regulatory inspections
- Support 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.
- Manage deviations/investigations, Out of Specifications, CAPAs, change control, product complaints, recall, and health hazard assessments in compliance with internal procedures.
- Manage the Material Review Board to provide final disposition of Non-Conforming Materials.
- Provide final release and approval for distribution for drug substances/products manufactured for clinical and commercial use.
- Support Maintenance of Design History Files and associated combination product documentation
- Contribute to the development of the annual Quality Plan. Manage deliverables to key milestones.
- Conduct QA review of GxP documents, when required.
- Develop and ensure GxP training for relevant internal staff. Maintain GxP training files and monitor compliance of staff GxP with training.
- Oversee 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.
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