Senior Manager, Document Control

Senior Manager, Document Control
Req#: 51320033




 

At Elan, we hold a fundamental belief that our science has the potential to improve patients? lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.


Elan?s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



PRIMARY OBJECTIVE:


Manage the Quality Assurance documentation operations for Elan's development products in South San Francisco. Ensure the timely approval and cGXP compliance of all controlled documents. Assures all documents are maintained in a state of cGXP compliance. Audit all the users of the documentation control system to ensure their full compliance to the system. Supervise the documentation group in a daily basis. Provide quality leadership in completing investigations and resolving deviations or special problems as they arise. Provide on-time customer service to users of the document control systems and provide metrics for periodic management review.

DUTIES/RESPONSIBILITIES:


- Manage the controlled documentation system encompassing the generation, revision, issuance, distribution, maintenance, and archival of documentation under QA control. Issue controlled documents to production and development staff such as production records, SOPs, and testing datasheets. Inventory completed testing records and assure controlled long term archival and duplication. Maintains history files of SOPs, equipments files, and other controlled documents. Assures preparation of controlled documents within the timetables needed and that appropriate review and approvals are obtained before implementation of new documents and controlled changes of documentation. 40%

- Provide technical review of SOPs and challenge changes and rationale of procedure revisions and the need for change control. Routinely hold SOP meeting to resolve issues and expedite completion. 15%

- Act as Project Manager for development and launch of EDMS. Assess, on continual basis, the usability and benefit of the various computer programs for document control. Coordinate the implementation and harmonization of documentation systems with other Elan sites. Represent the QA and Pharmaceutical Development on the ERIC project team as the Document Coordinator and Change Control Committee member. 15%

- Organize product release documentation prior to archiving to facilitate easy retrieval of documents. Routinely evaluate current filing system in the archive to ensure maximum control of the documents at all times. 10%

- Scrutinize all documents before forwarding to Regulatory for FDA submissions.
Establish a backup system for all archived documents (i.e., scanning, imaging system) including outside storage of documents. This will include organization, scanning schedules, implementation, oversight, access to users, archival and storage, and retrieval. 10%

- Provide the Introductory GMP Training and the Good Documentation Practices Training to Pharmaceutical Development and QA staff. Maintain all Pharmaceutical Development and QA training records. 5%

- Provide a strategic plan of the QADCC space and staffing. 5%

TRAVEL:


Minimal to no travel required.


MINIMUM EDUCATION/EXPERIENCE:


B.S. in chemistry, biology or related scientific discipline and 5-7 years experience in QA document control in a biopharmaceutical industry. Experience with Quality Assurance responsibilities of pharmaceutical operations and knowledge of cGXPs. Knowledge in biopharmaceutical documentation and label control. A proven record of effective interaction with operations staff and contractors (manufacturing and testing) regarding documentation.

PREFERRED EDUCATION/EXPERIENCE:


BS in a technical or scientific discipline and 5-10 years experience in a GXP industry handling/managing documentation systems.

SPECIAL TRAINING:
 
Experience and training with Electronic Data Management Systems (e.g., Documentum).

SKILLS/ABILITIES:


Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors. Must be able to coordinate the flow of documents between QA and other departments. Skilled in word processing and database computer applications.

 

 Click Here to Apply Online