Senior Associate -Controlled Document Management

This position has responsibility for the maintenance of the Document Management program across multiple disciplines within the R&D organization including but not limited to the coordination of documentation systems to ensure compliance, control, accountability, traceability, communication, retrieval and archiving of critical documentation throughout the lifecycle of the documents, including routing and issuance, and to provide timely customer service to all departments. This position will also act as a liaison between IT and the business for software and related process & continuous improvement projects. 

• Maintain and control the Document Management System (EDMS), i.e. QUMAS, to meet regulatory compliance. 

• Prepare and review SOPs and Process Deviations and ensure the submitted documents meet R&D controlled document quality standards. 

• Assure controlled documents are appropriately reviewed and approved prior to implementation via the change control process. 

• Maintain and coordinate activities related to the document system including generating, revision, retiring the requirements and operational procedures for internal and external documents. 

• Provide expertise and input to other functional areas affecting controlled documents. 

• Generate and publish metrics and reports related to the quality system. 

• Maintain history files of SOPs, Forms and other controlled documents in strict compliance to departmental policies, regulations and standards. 

• Ensure controlled documents are periodically reviewed for compliance. 

• Assist in the preparation and coordination with requests from regulatory authorities and other compliance inspections / audits. 

• Independently manage a diverse array of projects and tasks with a collaborative style. 

Education 

B.S. degree required, science degree preferred 

Experience 

• Minimum five (5) years’ experience in the pharmaceutical industry 

• Experience managing electronic document repositories 

• Experience writing and creating standards for document management 

• Knowledgeable in FDA expectations is essential, demonstrated experience reading and interpreting regulatory documents 

• Direct experience in GXP compliant quality systems is preferred 

• Experience using QMAS or similar EDMS 

Skills 

Attention to detail 

Excellent communication skills including: PC skills and good questioning and analysis techniques desired. 

Must work effectively in a team environment and with individuals at all levels within an organization. Additional necessary characteristics include: being a self-starter, goal oriented, and ability to multi-task.