Sr Manager, Quality Document & Records management

GENERAL SUMMARY:

4DMT is hiring a Sr. Manager Quality Document & Records Management. Reporting to the Sr. Director of Quality Systems and GCP Compliance the Sr. Manager will be responsible for ensuring 4DMTs Quality Document & Records Management is designed and executed in an efficient compliant and inspection ready manner.

This individual serves as the process owner for the quality document and records management system ensuring compliance with applicable GxP regulations industry standards and internal addition to driving process improvements and system optimization this role will perform operational tasks to support document and record lifecycles.

This role can be in-person or hybrid. If Hybrid the role will require regularly scheduled time on-site at 4DMTs Emeryville office at least monthly.

RESPONSIBILITIES:

Quality Document Control & Records Management System & Process Owner - 50% of the time:

• Serve as the primary point of contact for the Document Control system and quality-controlled records management.
• Develop enforce and improve policies procedures work instructions templates and forms related to document and records management.
• Collaborate closely with stakeholders (e.g. legal clinical regulatory IT) to align record policies and lifecycles across platforms.
• Oversee centralized and decentralized quality-controlled record repositories (physical and electronic) for completeness integrity and retrievability.
• Drive inspection readiness by ensuring all quality-controlled records are accessible traceable and compliant with data integrity and protection requirements.
• Lead or support record audits gap assessments and remediation plans in preparation for regulatory inspections.
• Lead user requirement definition system change verification validation document review and user training.
• Monitor trend and report document control metrics (e.g. cycle time overdue documents)
• Support internal and external audits and inspections.
• Provide guidance and training to system users and support documentation governance across departments.
• Hire manage and develop staff and/or contractors.

Quality Document Control & Records Management Operations - 50% of the time:

• Perform document intake formatting metadata review routing publishing and obsoletion and ensure timely review approval and release.
• Advise document control participants on content and format to meet 4DMT procedural requirements standards templates and best practices.
• Ensure compliance with document control procedures and applicable regulations.
• Collaborate with Quality Training to coordinate document and training lifecycles.
• Facilitate quality-controlled records management (e.g. onsite and off-site secure storage retention destruction)
• Identify and implement innovative methods to increase efficiency of operational tasks.

QUALIFICATIONS:

Education:

• Bachelors degree required preferably in a scientific technical or related field.

Experience:

• 8 years of experience in document control and records management within the biotech pharmaceutical or medical device industry
• 2 years in a hands-on system and/or process ownership role for a GxP EDMS (e.g. Veeva MasterControl ACE)
• 2 years leading or supporting GxP records management operations.
• 4 management experience
• Comprehensive knowledge of FDA EMA ICH requirements and industry best practices for document control and records management
• Practical experience leading or actively participating in at least 1 EDMS or EQMS system implementation and/or significant enhancement project.
• Exposure to audits and health authority inspections ideally in a commercializing biotech environment.
• Domain knowledge of clinical research and development manufacturing quality and/or IT is highly desirable.

Skills:

• Extensive experience in document formatting using MS Word
• Solid working proficiency in other productivity tools (e.g. Outlook Teams SharePoint Excel PowerPoint Forms DocuSign Adobe Acrobat).
• Basic knowledge of or willing to learn analytical and reporting tools (e.g. PowerBI).
• Foundational understanding of change management principles

Key Competencies

• Excellent interpersonal communication skills both written and verbal.
• Highly organized with the ability to multi-task and perform effectively under pressure.
• Proven project management problem-solving and organizational skills
• Demonstrated ability to collaborate influence and negotiate effectively.
• Motivated to seek out training and mentorship for professional development.

Base salary compensation range: $160000/yr - $210000/yr

Please note that compensation varies based on individual experience location skillset etc.