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 Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada.
GMP QUALITY ASSURANCE & COMPLIANCE
This position will report to the Head of Regulatory Affairs and will be responsible for Good Manufacturing Practice (GMP) Quality Assurance and Compliance (QA/C) at Akcea. The primary responsibilities will be to ensure quality and compliance of Akcea-sponsored
manufacturing activities with respect to relevant Standard Operating Procedures, applicable Regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and practices.
The successful candidate will be able to: (1) oversee responsibilities of GMP QA/C consultants and external auditors; (2) coordinate, schedule and prepare for audits in accordance with established GMP QA/C goals and objectives; (3) communicate internally
on upcoming audit(s) and schedule the audit(s) in cooperation with other relevant internal departments/functions as well as external vendor(s) and manufacturing sites; (4) effectively conduct the audits, draft and submit audit reports to relevant functions
for review and input; (5) communicate audit results to Management and stakeholders, and support process improvement activities as a subject matter expert (SME) in GMP; (6) assist in the inspection readiness activities; attend manufacturing trial team meetings,
as necessary; (7) stay current with new or revised regulations
- Support the development and implementation of the long-term Quality strategy for Akcea business model and provide overall quality oversight of manufacturing activities according to 21 CFR 820; ISO9001, cGMP and laboratory related compliance Standards/Regulations.
- Maintain up-to-date knowledge of FDA, EU and other global regulations and guidance governing Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) activities.
- Develop and embed Akcea Quality culture into business processes which support GMP including with suppliers, external CMOs, CROs and Contract Laboratories, as appropriate.
- 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.
- Chair the CAPA and Non-Conforming Materials Boards, coordinate/manage CAPA efforts and interact with customers (internal and external) on a timely manner and inform Management and relevant customers periodically of progress relating to issued CAPA’s, and
conducts and or coordinates complaint investigations.
- Contribute to the development of the annual Quality Plan. Manage deliverables to key milestones.
- Conducs risk-based audits of service providers and internal systems involved with Akcea manufacturing programs. Maintains Audit Files and Tracking Log.
- Conduct QA review of draft GMP and GLP documents, when requested.
- Act as main Company contact during FDA inspections, Notified Body (Management Representative), customer audits and other third party Quality System evaluations
- Establishes contract agreements and Statement of Works (SOWs) with the contract auditors according to the internal process with Akcea’s Legal input.
- Develop and implement training for relevant internal staff. Maintain GMP training files and monitor compliance of staff GMP with training.
- 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.