Manager of Document Control
The Manager/Sr. Manager of Document Control will oversee documents (both electronic and paper copies) within Quality Assurance, Regulatory Affairs, and other key departments at Neurocrine to ensure that all GXP regulated documents are filed systematically and are easily retrievable. Duties will include management of GXP records, lifecycle management of records, maintenance of the document database, and troubleshooting document issues and requests.
Essential Duties and Responsibilities (including, but are not limited to):
- Oversee the receipt, filing, and maintenance of all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, product complaints, computer system validation, etc.
- Design and implement an enterprise wide document repository that tracks the receipt, revisions, and archiving of all GXP documents.
- Prepare any supportive process workflows and procedures for the new document repository to maintain efficiency and access for all users.
- Maintain GXP audit files and assist with entry, tracking, and archiving of audit records.
- Oversee and administer document lifecycle management as well as the document change request process.
- Function as the administrator for our Learning Management System (LMS).
- Maintain all users, curriculum, and training records within the LMS.
- Responsible for the integration of the LMS with the enterprise document repository.
- Creation and development of processes, archiving, and operations related to document control.
- Perform review of documents submitted through the change control process for format, completeness, review and approvals. Issue controlled document copies to internal and externals requestors.
- Process document requests to be used in-house or sent to CSPs in a timely manner.
- Provide guidance and training to staff regarding document control processes.
- Other essential duties as assigned.
- Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment.
- Strong EDMS and computer skills to include Excel, Word, Adobe Acrobat, PowerPoint, Visio, DocuSign, Compliance Wire, Open Text CS10, Veeva Vault, and Veeva Quality Docs.
- Attention to detail, critical thinker, and effective organization skills required.
- Strong communication and proficient soft skills.
- Works well in a team environment with the ability to drive results.
- Ability to solve problems and work collaboratively in a team environment.
Education and/or Experience:
- B.S. Degree in a related scientific field desired.
A minimum of 10 years of experience within the pharmaceutical/biotech field performing document management and electronic document management.