Quality Systems Document Control Specialist

A growing pharmaceutical company with an exciting pipeline of therapies for neurological disorders is seeking a add a Quality Systems Document Control Specialist (contract to hire). Our client is in the process of building the Quality function to support late-stage clinical development programs is and preparing for commercialization. This position will be a key contributor to managing and improving the Document Management and Records Management Systems. This is a contract to hire position out of Boston, MA.

• Bachelor’s degree with at least 5 years of experience in a quality role, preferably within a broader quality organization supporting both development and commercial programs .
• Previous experience with implementing and maintaining electronic systems (e.g., Veeva, Compliance Wire, Master Control etc.)
• Previous experience with analytics for use in managing quality issues enabling a risk-based approach.
• Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having a willingness to do hands on work to achieve goals.
• Proven ability to work independently and collaboratively as part of a multidisciplinary team.
• Proficient negotiation and conflict resolution skills.
• Ability to travel if needed (less than 10%)

• Manages initiation, processing, routing distribution and achieving controlled documentation.
• Serve as the subject matter expert for the electronic document management system (eDMS) ensuring Controlled Documents are processed in accordance with SOPs including creation, revision, approval, and obsolescence.
• Collaborates closely with FALs within Development to determine document needs, establish, and improve necessary document templates, and provide guidance on project needs and maintain compliance with good documentation practices and GxP data integrity requirements.
• Partners with functional areas to conduct periodic review of existing GxP procedures.
• Manage delivery, maintenance, and continuous improvement of GxP processes in eDMS
• Oversees Document Control and GxP records management. Ensures adequate systems are in place to achieve and maintain records retention compliance pursuant to policies and regulatory requirements.
• Report data related to the health of the DMS to Senior Executive Team via the Quality Management Review.
• Own and facilitate the SOP Review Committee
• Manage the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides
• Ensure internal formatting standards are maintained
• Champion the execution of QS activities within document control within the QA department as well as cross functionally.
• Support computer systems validation and assist with the management of electronic document management systems.
• Provide high levels of support for the enterprise as it relates to achieving documentation deliverables
• Participate in regulatory inspections and/or internal audits.
• Establish and manage effective cross-functional team communications and advise on strategy and implementation of quality principles as well as regulatory requirements while remaining independent.
• Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality