Manager, Document Management

Summary of Job:

The Manager of Document Management at RegDev, Inc. is a key role responsible for leading the Document Management Team.  They will be responsible for ensuring a robust document management process internally and at our clients as required.  They will be the subject matter expert to perform gap assessments across RegDev documentation ensuring all documents are in compliance with global regulations where necessary.  This role is responsible for maintaining the document and record control systems to support a robust Quality Management System. This role is responsible for coordinating the issuance, revision, review, and approval of SOPs and other documents.

Essential Duties and Responsibilities:

• Leads the Document Management Team in the implementation and management of the document management system.  Determine resource needs and manage internal and external resources.
• Authors new SOPs and/or documents, manages existing documents, and coordinates revisions based on regulatory changes.
• Leads the process of document change orders (DCOs), routing and tracking of new and revised documents for approval following required processes.
• Manages all projects the Documentation Management Team is responsible for ensuring timely completion.
• Reviews of documents for completeness and adherence to company guidelines for formatting.
• Files electronic storage of documents and records, and other required documentation, and ensuring that all documents follow all document management processes.
• Communicates issues effectively and partners with cross-functional team members to meet deadlines.
• Assists in internal audits.
• Supports the establishment and improvement of quality systems and facilitates continuous improvements efforts of the Quality System.
• Updates and maintains quality metrics as needed.
• Performs other related duties as assigned.

Job Requirements:

• Education:  BS degree in scientific area preferred, or equivalent.
• Experience:
  • Quality professional with a minimum of 5-7 years of hands-on experience in the life science industry including a minimum of 3 years leading document management teams.
  • Experience developing, maintaining and performing gap assessments on standard operating procedures against regulatory requirements.
  • Must have working knowledge of global regulatory agencies and their standards.

Other Skills and Abilities:

• Excellent written and verbal communication skills.
• Good writing skills, high degree of organization, and excellent attention to detail.
• A successful candidate will also demonstrate an ability to work independently and as part of a team.
• Good computer skills with working knowledge of the MS office suite, SharePoint, and Adobe Acrobat.
• Self-motivated and able to organize and prioritize multiple tasks.

ADA Notations:

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
• Regular communication (hearing/speaking)
• Approximately up to 10% domestic travel.
• Lifting up to 25 lbs
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

Equal Opportunity Employer