Document Control Manager

About the role

10x Genomics was founded to deliver powerful and reliable tools that fuel key scientific discoveries and drive exponential progress in our mastery of biology to advance human health. Our talented team has a distinguished record of creating innovative instruments, reagents, and software that analyze biological systems at a resolution that matches the complexity of biology.

Currently ISO 9001 certified, we are actively working towards ISO 13485 certification to further enhance our quality management systems. We are seeking a dedicated and experienced Document Control Manager to join our team. This role is critical in managing and maintaining our Quality Management System (QMS) documentation, ensuring compliance, and supporting overall quality objectives.

The Document Control Manager will oversee all aspects of document management, including the creation, review, approval, distribution, and archiving of quality documents. This role demands meticulous attention to detail and the ability to manage documentation processes efficiently to meet ISO 13485 standards without adding unnecessary bureaucracy to RUO products. A flexible and adaptive leader and highly driven self-starter with good communication skills, collaborative attitude, resilient mindset and optimistic outlook will be the happiest here.

What you will be doing:

• Establish and maintain an effective document control system to manage the lifecycle of quality documentation.
• Ensure that all documents are reviewed, approved, and distributed in a timely manner.
• Control the distribution of documents to ensure access to the most current versions in PLM.
• Ensure that the document management processes comply with ISO 9001, ISO 13485, and other relevant regulatory requirements.
• Conduct regular audits of the documentation system to verify compliance.
• Coordinate the creation, revision, and approval of SOPs, work instructions, quality manuals, forms, and other documents.
• Collaborate with cross-functional teams to ensure documents adequately reflect current processes and standards.
• Provide training and guidance to employees on document control procedures and QMS requirements.
• Support all departments in understanding and implementing document control requirements.
• Identify opportunities for improvement in document control processes and implement changes to enhance efficiency and compliance.
• Lead initiatives to optimize document control systems and software tools.
• Contributes to advance change management, PLM, ERP systems and processes.
• Develop and manage document archiving processes to ensure secure and accessible storage of records.
• Maintain and follow document retention schedules according to relevant requirements.

Minimum Requirements:

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Minimum of 5 years of experience in document control in the life sciences or medical device industry.
• Experience with ISO 13485 documentation requirements is strongly preferred.
• Comprehensive understanding of document control principles and QMS requirements.
• Excellent organizational and time management skills.
• Strong attention to detail and ability to handle large volumes of documentation.
• Proficiency in document management software, Microsoft Office Suite (Word, Excel, PowerPoint), Google Docs (Docs, Sheets, Slides).
• Exceptional communication and interpersonal skills.
• Strong technical writing skills are a plus.
• Knowledge of GD&T & awareness of manufacturing best practices are a plus.

Preferred Skills & Attributes:

• Ability to work independently and as part of a team.
• Proactive and able to identify and solve problems effectively.
• Curious to learn and try new things and develop new skills.
• High level of integrity and professionalism.

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