Associate Director, Quality Management Systems

Ardelyx•Waltham, MA

1d•Hybrid

About The Position

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative 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. This position is hybrid-based requiring 2-3 days onsite in our Waltham, MA office. Position Summary: The Associate Director, Quality Management Systems , is responsible for the oversight of the Change Control process, Quality Events/CAPAs and supporting Veeva Systems. This includes leading Change Control and Deviation/CAPA Review Boards, gathering Quality Metrics for reporting 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 Change Control, Quality Event and CAPA processes, support other QMS processes and lead change in the organization. This role will report to the Executive Director, Quality Management and GXP Systems.

Requirements

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/Governance, Deviation/Investigation, CAPA, and Quality Metrics reporting
Experienced in Veeva System or other Quality Management Systems
Demonstrated ability to solve problems, troubleshoot and organize priorities
Must have excellent attention to detail
Excellent communication and time management skills
Good presentation, verbal and written communication skills
Ability to manage projects and lead cross functional teams in a fast-paced environment
Demonstrated experience in leading, managing and improving pharmaceutical quality systems
Strong leadership, technical management, problem solving and project management skills
Ability to quickly understand issues, needs and articulate potential solutions in fast paced environment

Nice To Haves

Ability to travel as needed (15-20%)

Responsibilities

Serve as the Process Owner for Change Control and Quality Event/CAPA, leading cross-functional teams to manage QMS processes and ensure all procedures remain compliant with regulatory requirements, quality standards, and strategic business goals
Responsible for continuous improvement of Change Control, Quality Event and CAPA Processes
Ensure processes are scalable to support commercial products and new R&D projects, including improving processes to support increased production, new markets and new projects
Lead Change Control impact assessments in partnership with Tech Ops, Supply Chain, Regulatory, and QA to evaluate implications and ensure all actions are completed according to the approved Change Plan
Lead and manage Change Control, Quality Event and CAPA Boards
Ensure Change Plans are executed with objective evidence by overseeing that all changes are documented, risk-assessed, approved, and closed in a controlled and timely manner
Ensure Quality Events/CAPAs are documented with detailed investigation analysis/ assessment, root cause analysis, interim corrective actions and preventative action and effectiveness checks
Gather and report Change Control, Quality Event and CAPA Metrics on a monthly and quarterly basis. Reporting at various boards, governance meetings and Management Review
Develop, implement, and maintain Change Control, Quality Event and CAPA Training programs, including educating the business on best practice, regulatory requirements and process
Lead and support Internal Audits as SME for process and back-room documentation needs
Serve as the Veeva Subject Matter Expert by leading system upgrades and improvements in collaboration with vendors and business users to enhance process efficiency
Act as the Subject Matter Expert in Veeva and lead/support system improvements by leading system upgrade and changes to Veeva by partnering with the vendor and business users to enhance process efficiency
Drive inspection readiness by leading mock inspections, storyboards, and training while supporting on-site and remote regulatory audits through front- and back-room roles, including SME, scribe, and co-host
Manage and coach direct and indirect reports along with consultants or contractors