Document Control Systems Program Manager

Job Description:

POSITION SUMMARY

The Document Control Systems Program Manager is responsible for the leadership, implementation, maintenance, governance, and continuous improvement of enterprise document control systems. This role ensures that documents, records, and data are managed in compliance with internal policies, industry standards, and regulatory requirements while supporting business efficiency, system adoption, and data integrity across the organization.

The Program Manager acts as the primary owner of document control platforms (e.g., EDMS, PLM, eQMS), overseeing system configuration, integrations, user adoption, training, audits, and cross-functional coordination.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• Primary responsibility being the system owner for document control platforms across all systems

• Support document control system validation activities and periodic maintenance including system upgrades/process harmonization efforts.

• Lead system implementations, upgrades, migrations, and decommissioning efforts.

• Execute and maintain defined governance and standards.

• Ensure accurate document metadata, revision/version control, and access permissions

• Ensure compliance with all applicable regulations and standards.

• Creating and maintaining document templates and numbering systems

• Partner and collaborate cross-functionally

• Responsible for execution of Document Change Orders in support of manufacturing, engineering and other departments, as necessary in accordance with policies and procedures.

• Support training assignments and activities.

• Provide end user support and training on document control and training process.

• Maintain Training Files for the company.

• Help to establish KPIs and metrics within systems

• Audit readiness.

• Perform other TransMedics tasks and duties as assigned/required.

MANAGEMENT RESPONSIBILITIES

• No management responsibilities

PHYSICAL ATTRIBUTES

• Lifting up to 25lbs                                                                                                           

MINIMUM QUALIFICATIONS                                                                                            

• Bachelor's degree or equivalent combination of education and experience.

• 3+ years in a management role

• Minimum of 5 years’ experience in Documentation Control / Quality / Life Sciences or related field

PREFERRED QUALIFICATIONS

• Medical Device experience preferred.

• Experience with eQMS/PLM platforms and system validation principles

• Familiarity with regulatory and quality standards

• Excellent program management, communication and stakeholder management skills

• Experience with digital transformation

• Strong attention to detail and document accuracy

• Excellent organizational and communication skills

• Proficient in Microsoft Office

• Audit experience

• A working knowledge and/or experience in the following areas:

  • Label software experience preferred

  • Experience working with an MRP interfacing system

• Experience working in a fast-paced environment as part of a cross-functional team

• Demonstrated track record working with limited direction to produce high quality work

• Proven ability to provide logical, in-depth analysis of a problem or situation

As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ tr