Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. 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.
Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.
In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”
In the third quarter of 2017, we plan to file a marketing authorization for volanesorsen to treat patients with FCS and are seeking talented professionals to support our efforts.
DIRECTOR, GCP QUALITY ASSURANCE & COMPLIANCE
This position will report to the Head of Regulatory Affairs and will be responsible for Good Clinical Practice (GCP) Quality Assurance and Compliance (QA/C) at Akcea. The primary responsibilities will be to ensure quality and compliance of Akcea-sponsored
clinical trials 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 GCP QA/C consultants and external auditors; (2) coordinate, schedule and prepare for audits in accordance with established GCP QA/C goals and objectives; (3) communicate internally
on upcoming audit(s) and schedule the audit(s) in cooperation with the Clinical Operations and other relevant internal departments/functions as well as external vendor(s) and investigator sites; (4) effectively conduct the audits, draft and submit audit reports
to head of the GCP QA/C for review and input; (5) communicate audit results to stakeholders and support process improvement activities as a subject matter expert (SME) in GCP; (6) assist in the inspection readiness activities; attend clinical trial team meetings,
as necessary; (7) stay current with new or revised regulations
- Supports the development of the long-term Quality strategy for Akcea business model and overall quality oversight.
- Develop and embed Akcea Quality culture into business processes which support GCP, GLP, GMP's including suppliers, external CMO's, CRO's and Contract Laboratories.
- Maintains working knowledge of FDA, EU and other global regulations and guidance governing Good Clinical Practice (GCP), Pharmacovigilance (PV) and Good Laboratory Practice (GLP) activities
- Ensures the quality & compliance of Akcea’ clinical development & clinical operations activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
- Prepares and conducts or assists contract auditors for GCP audits per established strategies
- Maintains Audit Files and Tracking Log
- Conducts QA review of draft protocols; ICFs, and other clinical trial specific documents, when requested
- Conducts QA review of Clinical Study Reports and communicate findings to the appropriate team
- Conducts risk-based audits of service providers, internal systems and clinical investigators involved with Akcea clinical trial programs
- Establishes contract agreements and Statement of Works (SOWs) with the contract auditors according to the internal process with Akcea’s Legal input
- Assists in the maintenance of GCP training files and in the compliance monitoring of staff GCP training
- Assists in the review of clinical trial related SOPs
- Executes other duties as delegated
- Bachelor and/or Masters in a healthcare and scientific-related discipline is highly desirable
- 10 years of GCP/GLP/PV quality assurance experience in a pharmaceuticals or biotechnology industry. Additional experience of GMP quality assurance is highly desirable
- Experienced understanding of Clinical Development Process
- Experience writing and reviewing SOPs which support clinical trials and associated processes and functions
- Good understanding of FDA GCP and ICH regulatory requirements and implementation
- Good knowledge of Computer System Validation in association with GCP/GLP/PV/GMP audits
- Effective communication (verbal and written)
- Strong interpersonal skills, team player, and flexible without compromising quality
- Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
- Ability to travel 30% (domestic and international), sometimes on short notice
- An ability to be productive and successful in an intense work environment
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website:
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.