Position: Senior Manager, Quality Assurance-System and Document Control
Department: Regulatory Affairs
Reports to: Senior Director, Quality Assurance
Location: CA (SF Bay Area or San Diego)
Connect Biopharma (Nasdaq: CNTB) is a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research. With clinical development activities in the United States, China, Europe, and Australia, and operations in those geographies as well as Hong Kong, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.
Sr. Manager, Quality Assurance-System and Document Control will play a critical role in implementing and managing an electronic quality management system (EQMS). This key role is responsible for the document management of change control activities, preparing metrics, APQR, and supporting regulatory filings. Additionally, this individual will work independently to oversee data integrity for both paper-based and electronic systems ensuring all activities performed are compliant with an applicable internal quality management system and regulatory guidelines.
- Manage and organize the existing quality and other corporate documents. Align naming conventions and attributes of paper-based quality documents to EQMS for migration.
• Life cycle management of controlled documents including creation, review, approval, and retirement per the internal QMS and SOPs.
• Prepare quality metrics and APQR.
• Manage clinical and other GxP-related documents for regulatory filings.
• Manage uploads and storage of CMO’s MBR, EBR, contractor manuals, QAGs, and documents from third-party service providers such as CROs and CTLs.
• Review documents for accuracy and completeness, identify and fix errors, and format to align with the internal quality management SOP requirements.
• Develop, execute, and maintain a role-based training curriculum.
• Collaborate with stakeholders to develop department-specific controlled documents, GxP core training, and training matrices.
• Prepare metrics and continuously track the status of compliance risk related to training and other controlled documents and report to management.
• Assist in performing internal and external audits, including preparing reports.
• Prepare metrics for CMOS/CROs/CTLs performance.
• Establish Inspection Readiness activities and metrics and serve as the primary point of contact for providing all documents during audits and inspections.
• Work collaboratively with various functional stakeholders in a matrix environment to drive continuous improvement initiatives and excellence.
BA/BS in a science field is preferred. At minimum, an associate’s degree with 7 years of relevant experience
Qualifications And Requirements
- The ideal candidate will possess at least 5 years of experience within the biopharmaceutical industry in a GxP environment, including experience in the implementation/maintenance of electronic document management systems, curriculum design, and training.
• Experience with both manual and electronic document management systems.
• Ability to author, edit, format, and critically review controlled documents and SOPs.
• Experience in a virtual company overseeing documents uploads related to CMOs, CROs, investigator sites, and other clinical service providers is preferred.
• Ability to collaborate in a multinational environment to achieve shared goals and objectives; prior experience building Quality functions within an emerging global company is also an advantage.
• Experience in providing back-room support during audits and regulatory inspections.
• Strong critical thinking, problem-solving, influencing, and exceptional attention to detail.
• Ability to multi-task, prioritize options, anticipate challenges, and execute on goals as an interdisciplinary global team member is essential.
• Excellent organizational, written, and verbal communications.
• Proficient with MS Office applications, Excel, PowerPoint, Visio, etc. required.