Responsible for leadership of the Corporate GxP document control and training functions. • Collaborate with leadership to create and execute the Corporate QADC and Training strategy. The strategy will ensure that QADC and Training have the necessary structure, processes, tools, and knowledge to meet the company’s current and future needs.• Collaborate with internal IT staff and vendors to ensure the optimal configuration and performance of the company’s EDMS.• Collaborate with leadership to proactively optimize cross-functional processes involving QADC and Training, and in solving potential workload or compliance issues.• Lead the Corporate QADC and Training teams to achieve their assigned objectives.• Help ensure documentation and training practices are comply with all internal procedures, and Health Authority regulations and guidelines.• Collaborate with document owners and their supervisors assist the creation, review, and approval of controlled documentation. • Ensure that various QADC and Training reports are generated as required.• Ensure adequate QADC and Training support is provided for all audits and Health Authority inspections.

Responsible for the implementation and management of Audentes' quality documentation system and ensuring that documentation and systems are in a state of compliance with current regulations. Also the responsible process owner for all document management procedures. The role will translate strategy into action; propose and lead implementation of quality improvements to document control systems and processes to improve efficiencies.

Manage global staff of seven Procedure Administrators within the Pharmaceutical Sciences Quality Systems and Compliance group, providing document control support.Responsible for oversight of documentation and records support at PharmSci sites - San Francisco (CA), St. Louis (MO), Andover (MA), Groton (CT), Chapel Hill (NC), Sandwich (UK), and Melbourne (AU)- Serve as primary contact for PharmSci SOP Portal (Sharepoint)- Business Line SME for document management system (Documentum)- Monitor and report on periodic review of SOPs- Prepare monthly metrics for SOPs- Author and update area SOPs and BPs as needed- Serve as Active Library Lead and provide oversight to record libraries at sites

Manage staff of four to provide document control support. Responsible for ensuring proper and timely execution of controlled document processes. Conduct assessments of complex electronic workflows and business processes to recommend solutions and improvements- Serve as controlled document subject matter expert (SME)- Represent Document Control team as department lead in cross-functional meetings and projects - Lead the implementation of document control process improvements- Author and update controlled document procedures as needed- Manage and maintain controlled documents in MasterControl- Independently review SOP/Work Instruction content and provide suggestions to author- Assist in the development, administration and validation of eQMS- Lead execution of UAT of MasterControl and PleaseReview during validation- Track controlled documents to ensure reviews and approval are completed within MasterControl.

Responsible for Quality Systems in support of GxP activities:- Manage document control function for internal and external documents.- Manage training program for GXP employees.- Review and approve testing of reference standards by Analytical Development.- Administer systems for DR-CAPA and product complaints.- Author SOPs for QA business processes.

Responsible for the Document Control function to ensure compliance with cGMP regulations. Will assess and recommend quality system improvements including full utilization of existing technology. Also support general QA activities including deviation and CAPA tracking and trending, batch record review, and employee GMP training. Maintain GxP files.

Manage business analysts in support of Quality IT systems used worldwide. Systems include Document Management (LiveLink), Deviation Management (TrackWise), and Learning Management (WebTraining).

Managed staff of 10-15 in buffer and media preparation, and glassware support for R&D and Manufacturing. Developed buffer formulations and authored SOPs and Batch Records for GMP areas.