Position:
The Senior Director, Quality Systems will serve as a subject matter expert and will assist in the implementation and maintenance of GxP compliant procedures and operations by managing the GxP systems including electronic document management system and learning management system. This hands-on position involves system validation, document control, and continuous improvement initiatives, while collaborating with cross-functional teams to maintain and enhance quality processes in alignment with regulatory requirements.
Responsibilities include:
- Hands-on role implementing, maintaining, and enhancing the electronic systems throughout its lifecycle as it relates to Quality (EDMS, LMS, etc.)
- Contribute to the validation activities of GxP computerized systems, demonstrating expertise in both Computer System Validation (CSV) and the Computer Software Assurance (CSA) activities
- Accountable for maintaining GxP systems in their validated state
- Identify and support continuous improvement opportunities within Quality Systems
- Monitor, generate, analyze and report out Quality metrics to relevant stakeholders aimed to ensure the health of the quality system
- Set up and manage the document control process and ensure all controlled documents are appropriately stored, distributed, and archived in accordance with company and regulatory requirements
- Implement 21 CFR Part 11 compliance and ensure all electronic records and signatures are in compliance with regulations
- Set up relevant staff on Veeva Vault and ensure all document control processes are appropriately managed within the system
- Assist in the creation of training curricula and ensure all Annexon personnel are trained on relevant document control procedures
- Work with cross functional teams to ensure all documents are reviewed, approved, and trained on in a timely manner
- Conduct periodic audits of document control processes and ensure any non-conformances are appropriately addressed
- Participate in the development and implementation of new document control procedures as needed
- Maintain knowledge of current industry and regulatory trends related to document control and ensure company processes remain up to date and compliant
- Support and participate in other duties as assigned by management including but not limited to audits and inspections, supplier quality management, quality risk management, and quality management systems
Education, Experience, and Skills:
Required:
- Bachelor's Degree in a related discipline with a broad knowledge of biologics, device or drug development and at least ten (12) years industry experience related to GxP systems
- Knowledge of and proficiency with electronic document management systems (Veeva Vault experience is highly desired)
- Strong problem-solving and communication skills
- Ability to work independently and as part of a team
- Strong organization and time management skills
