A forward-thinking pharmaceutical company is looking for a dedicated Clinical QA Manager to join their Quality team. This is a unique opportunity to make a significant impact in the early stages of the company's growth by playing a pivotal role in ensuring the quality and compliance of clinical operations.
You will be responsible for planning and leading external clinical quality audits at clinical investigator sites and collaborating with contracted CROs and other service vendors. Your role will involve auditing internal GCP processes and documents to guarantee adherence to applicable regulations, including FDA and global regulatory standards, ICH guidelines, and SOPs.
Responsibilities:
- Manage and conduct clinical quality and system audits of vendors selected for clinical trial activities and data management, assessing their adherence to regulatory standards.
- Collaborate with Clinical Operations, Clinical, and Bioanalytical teams to assess vendor qualification and audit requirements.
- Perform clinical investigator site audits to ensure compliance with Study Protocol, associated documents, regulations, and guidelines.
- Analyze audit observations and address risks through CAPA both internally and externally.
- Represent QA on cross-functional teams and provide compliance advice and guidance.
- Ensure Quality Agreements are in place and adhered to, reviewing them regularly.
- Develop and implement relevant clinical and nonclinical QA SOPs as needed.
- Manage vendor risk assessments, including CROs and Contract Manufacturing Companies.
- Develop and support the creation of sponsor oversight SOPs and guidance documents.
Requirements:
- Bachelor's degree in a scientific discipline required.
- 5 years minimum of QA experience in a GCP setting for all phases of clinical trials.
- Experience auditing GCP vendors, internal GCP processes and documents, and clinical investigator sites.
- Profound knowledge of FDA and global regulatory standards, ICH guidelines and GCP.
- Strong grasp of quality risk management concepts.
- Proficiency in MS Word, Excel, PowerPoint, and Outlook.
- Up to 25% travel may be required.
