- Responsible for Oversight of R&D Quality and Compliance
- Contribute to Approval of Innovative New Medicines for Growing Biopharma Company
- Expanding biopharmaceutical company with highly specialized expertise in development of therapies to treat rare immunological diseases
- Prepares, conducts Quality Assurance (QA) audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g., Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
- Activities may include GCP and PV routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations and due diligence activities.
- Will represent QA as a single point of contact and provides QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries.
- Serves as a member of the project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.
- Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
- Contributes to the QA strategy and supports QA goals for the aligned studies/countries in a given TA/Region.
- Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.
- In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
- Leads in development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Minimum BS degree in Chemistry or related life sciences discipline required with
minimum 5-7 years of experience.
- Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional
years of equivalent experience will be considered.
- Experience with effectively managing regulatory agency inspection and working with
regulators and internal staff to help prepare for inspections is required.
- An understanding of drug and device regulations, development processes and HA
inspection procedures is required.
- English and Japanese fluency is required.
- Experience developing SOPs, reviewing internal clinical, pharmacovigilance,
regulatory and medical processes to ensure they are accurately represented in current
SOPs is essential.
- Ability to organize and conduct internal audits is necessary.
- Ability to conduct external audits on Investigator Sites, CROs, supporting laboratories,
and monitoring organizations with responsibility for writing audit reports as well as
reviewing and tracking QEs/CAPAs.
- Work in an international environment, clear career development opportunities, contribute to global clinical studies
- Work as part of Global R&D organization
- Contribute to approvals of new drugs in rare disease areas