Quality Documentation Systems Manager, Biotech

Documentation Systems Manager, Bioprocess DivisionAs a key player in the corporate quality organization, you will be responsible for ensuring Millipore's global company-wide quality documentation systems are effective, efficient and compliant with applicable regulations and standards. You will lead the development of innovative integrated e-platform solutions with a rationalized infrastructure that can meet Millipore's changing business needs. Together with your corporate based team (quality engineers and documentation specialists), you will be responsible for driving needed improvements across Millipore's global organization.You are an innovative strategic thinker with a results orientation. You are motivated by the opportunity to lead significant quality improvements in a rapidly growing company serving the pharmaceutical, biotech industry. As Millipore transitions its core quality systems to e-platform solutions, your role will be instrumental in ensuring the value from these systems is optimized.This position reports to the Corporate Quality Director, Bioprocess Division and will be based at Millipore HQ, Billerica, MA.Key Position Responsibilities
Lead the overall development, design and infrastructure management of electronic system solutions associated with the archival, storage and preservation of documents.
Develop and lead e-documentation and document security monitoring, audits and reporting to ensure compliance and integrity.
Develop rationalized effective solutions for Millipore's core company-wide documentation-based systems including policies, procedures, change control, customer notification, validation, certificates of quality, quality agreements and internal audits.
Building an effective labeling control system to include all documentation shared with customers related to claims on Millipore's products.
Lead the ISO compliance program, including integration with Millipore's other compliance and continuous improvement programs.
Provide periodic communications on changes to relevant regulatory and industry standards and regulations, as pertinent to Millipore's documentation systems.
Lead the development and use of metrics to optimize performance, productivity and effective resource planning.
Develop and lead training regarding the appropriate use of e-documentation solution platforms and document security.
Coordinate document management activities related to outsourcing, joint ventures, due diligence and R/D activities.Requirements
BS Degree in life science or records/library/archives management.
Min of 10 years work experience in a regulated environment, at least 5 years experience working in a similar role. Knowledgeable of current pharmaceutical industry and applicable regulations including ISO, GAMP, 21CFR Part 11, GxP, ICH etc
Demonstrated expertise and proven success with e-documentation platform development, solutions, security and project management.
Demonstrated managerial, teamwork and project leadership skills
Self-motivated; ability to learn quickly and to motivate others
Strong sense of urgency and ability to handle changing priorities
Excellent written and verbal communication skills
Strong interpersonal and customer service skills
Demonstrated problem solving and conflict management skills
Ability to lead and influence others across functions and divisions
Knowledgeable on documentation standards and systems, validation, process mapping and DMAIC methodology
Expert in database development and qualification
Ability to manage and develop people to create a high performance team
Proven ability to lead global cross functional teams
Change agent, future oriented and ability to develop innovative solutions
Acquisition and integration experience an advantage
Experienced in computer applications including Word, Excel, Access, Powerpoint, MicroSoft Project
Ability to travel globally (approx. 25%)
REQUIREMENTS
See Above / gj-hh