QA Document Control Manager
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
As Document Control Manager, you will lead the development, effective implementation, and continuous improvement of Document Management and Controls across multiple sites and business acquisitions. This position ensures that the Document Controls processes are in compliance with CAP/CLIA, FDA regulations, ISO and other regulatory standards. You will report to the Sr. Manager, Quality Assurance and will play a key technical leadership role for the software test organization.
- Manage and administer electronic Document Management System across sites and acquisitions to ensure compliance to applicable internal procedures, global regulatory requirements, and standards.
- Support update, review and approval of controlled documents, including procedures, work instructions, protocols, templates and technical documents.
- Become extremely well-versed in the electronic Document Management system and create company training materials in a timely manner.
- Implement Document Management solutions with a primary focus on Document Control and records management.
- Track, trend, and monitor metrics related to Document Management and Control, providing reports as necessary.
- Drives continuous improvement to support a sustainable framework for QMS document control activities to enable simplification and standardization.
- Collaborate with cross-functional partners to develop usable and compliant procedures, serving as a subject matter expert in regulatory compliance audits and inspections.
- Lead and drive audit actions and CAPA’s associated with the Document Management and Control.
- Ensure Document Controls are in compliance with CAP/CLIA and FDA regulations, as well as ISO and other regulatory standards.
- Collaborate with cross-functional partners such as Lab Operations, R&D, Regulatory, Medical Affairs, etc. to seek their input into the development of procedures, understanding the support they need and addressing their concerns and issues.
- Strategize on building efficiencies within Document Management and Controls.
- Oversee, mentor, and develop staff.
- Other duties and projects, as assigned
Required Education & Experience:
- Requires a Bachelor's degree or equivalent related experience, 10+ years of experience in a documentation-related position in a regulated environment, and 5+ years of supervisory experience
- Strong written and oral communication skills, attention to detail, and the ability to prioritize and organize a busy workload are also required
- Strong stakeholder management and ability to influence others
- Ability to lead and collaborate with a diverse team (entry level to seasoned) through growth and change, including internal and external challenges
- Experience with different electronic document management systems
- Intermediate to advanced working knowledge of medical device regulations and standards (ISO 13485:2016, FDA QSR)
- Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)
- Proven experience in working in a cross-functional team environment as well as the ability to function independently
- Ability to be open-minded, define and create solutions to challenges or opportunities
- Ability to communicate with all levels of technical and operations personnel
- Ability to gather and organize information
- Ability to create processes and workflows
- Ability to handle a variety of projects at the same time
- Proven ability to prioritize and organize a busy and changing workload
- Proven ability to manage assigned projects with little supervision
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.