Associate Director, Document Management & Training QMS

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan.

A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

The Associate Director, Document Management and Training QMS is responsible for the oversight of Document Management and Training Management Systems. This includes reporting Quality Metrics at QMS Boards and Management Review meetings. This role will also support internal audits, inspection readiness and regulatory authority inspections. In addition, this role will continuously improve GXP Document and Training processes and lead changes in the organization.

This role will report to the Executive Director, Quality Management and GXP Systems.

• Oversee the strategy, development, and management of GXP Document and Training programs and related documentation, ensuring processes, systems (Veeva/Compliance Wire), compliance (GxP), and content meet regulations, quality standards and business goals
• Develop and implement strategic plans for documentation and training, manages departmental goals, and leads cross functional teams
• Act as the Subject Matter Expert in electronic learning and document management systems managing user support, system improvements, and data (Compliance Wire, Veeva, etc)
• Lead system upgrade and changes to Veeva and Compliance Wire by partnering with the vendor and users/business on changes needed to support process and systems improvement
• Oversee periodic reviews of the controlled documents (such as Policy, SOP and Work Instructions) are performed and documented per SOP by working with the GXP business areas
• Ensure compliance with legal and regulatory standards for document storage and retention by partnering with Legal and other cross functional leaders
• Oversee company training program partnering with Compliance and Non GXP areas, including improving onboarding training experience and process with new employees
• Ensure appropriate training requirements are defined in job specific role curriculum/matrix, including gathering training records as requested for audits and regulatory inspections
• Oversee, create, implement and manage job specific curriculum/training matrix for GXP functional areas by partnering with GXP Business areas on curriculum training matrix
• Lead and manage periodic Document and Training Board meetings and Quality Management Review for oversight of document revisions, periodic reviews, training assignments, annual curriculum reviews and review metrics performance monthly with this cross functional team
• Lead and support inspection readiness activities and regulatory inspections on site and remotely, including inspection readiness training and process for inspections
• Manage and coach direct and indirect reports along with consultants/contractors

Please note: this position is a hybrid-based out of our Waltham, MA office and requires a presence on-site 2-3 days per week.

• Bachelor’s degree in science or related field with 8 - 10+ years of GxP Quality experience in life sciences industry or equivalent experience
• 5+ years of Hands-on experience in hosting internal/external audits and regulatory inspections
• Demonstrated experience in managing pharmaceutical quality systems such as Management Review, Document Management, Training, Deviation/Investigation, CAPA, and Quality Metrics reporting
• Experienced in Veeva, Compliance Wire systems other Quality Management and Training Management Systems
• Excellent communication and time management skills
• Good presentation, verbal and written communication skills
• Ability to project manage and lead cross functional teams in a fast-paced environment
• Demonstrated…