Position HR040 – Director, GCP/GLP Quality
Location: Bridgewater, NJ
Nevakar is a specialty injectable pharmaceutical development company, based in Bridgewater, New Jersey.
Products targeted for development by Nevakar are expected to address unmet clinical and commercial needs of currently available molecules, and thereby offer value proposition to patients, prescribers and payors. These products will be filed with FDA, primarily under the 505(B)(2) regulatory pathway.
The Director of GCP/GLP QA is responsible for leading the independent QA oversight of internal and external Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and assuring compliance of projects with applicable worldwide regulations and guidelines (e.g. FDA, EMA, ICH, national regulators). This position is also responsible for establishing and/or upgrading and maintaining systems to oversee GCP/GLP compliance programs as the company evolves towards late stage and commercial activities. This position reports to the Vice President and Head of Quality.
- In partnership with internal Clinical Operations, Medical Monitors, Drug Safety, and Pharmacovigilance, develop mid to long term Quality plans for oversight of internal and external clinical activities
- Lead risk and gap analyses of existing systems and processes; and propose improvements
- Act as a strong technical resource to resolve GCP/GLP issues based on knowledge of regulations, guidelines, and relevant SOPs
- Direct upgrade of QA systems and SOPs for late stage clinical and commercial activities
- Plan and oversee internal & external GCP/GLP audits including audits of clinical trial master files, call centres, and data facilities
- Effectively communicate audit outcomes and potential short and long term impact of deficiencies
- Proactively identify quality issues/discrepancies, communicate, and effectively resolve issues in collaboration with internal and external partners
- Make, and effectively communicate, decisions/recommendations based on the stage of drug development
- Contribute to QA by undertaking a variety of roles and assignments to further develop internal processes and personnel
- Lead, and revise as needed, an effective GCP/GLP training program
- Ensure compliance of clinical development with all applicable regulations and standards
- Lead preparations for regulatory inspections of our offices and its CROs as necessary
- Actively engage in activities to influence and meet changing needs of the regulatory environment through QA and other appropriate venues.
- Participate in and provide support for Quality Management Reviews
- University degree in life sciences or related fields; PhD desired, but BS/MS with relevant experience will be considered
- Expertise in GCP/GLP regulations and guidance of Health Agencies and ICH guidelines
- Able to influence without authority; experienced team builder
- Proven track record of activity in planning, organizing, motivating, and leading to achieve specific goals
- Must have excellent attention to detail, time management and investigative skills, as well as ability to manage multiple priorities with aggressive timelines
- Must have strong written and oral communication skills
- Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of various factors
- Advanced knowledge of computer software in order to perform trending and prepare presentations to management (MS Word, MS Excel, MS PowerPoint, etc.)
- Ten + years of direct experience in GCP/GLP Quality Systems and oversight of drug development lifecycle, clinical/non-clinical research, clinical study monitoring, or pharmacovigilance
- A minimum of five years of previous clinical QA experience conducting broad range of audits
- Direct experience in Health Agency inspection hosting
- A minimum of seven years’ experience in a staff leadership role, demonstrated leadership skills in hiring, mentoring, and developing staff