Senior/Executive Director, Quality Management System

About the role

The Senior/Executive Director, Quality Management System (QMS) will be responsible for driving and delivering the activities necessary to develop, implement, and continuously improve a phase appropriate GxP QMS. This role will be directly involved with both strategy development and day-to-day tactical execution related to QMS processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation, CAPA, Risk Management, and GxP Computer System Assurance.

Key Responsibilities

• Select, implement, manage, and oversee GxP electronic systems including any associated Purchase Orders and contracts.
• Develop, implement, manage, continuously improve, and oversee processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation/CAPA/ Risk Management, and GxP Computer System Assurance
• Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes
• Establish and improve policies and standard operating procedures for efficient and compliant management of GxP QMS processes
• Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings
• Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes
• Ensure that QMS processes comply with phase applicable regulatory standards, regulations and guidelines.
• Maintain awareness of new regulations, technologies, industry trends and best practices and apply them as may be relevant
• Manage resources to achieve company, department and functional area goals and objectives
• Contribute to the development and maintenance of a positive team-focused company culture
• Provide coaching as a manager and team member, make quality decisions and be Quality Approver as appropriate.
• Act as the primary QMS subject matter expert and point of contact for all related matters and issues.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Champion continuous improvement and simplification across quality systems.
• Contribute to building a strong quality culture within the organization.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, CMC and other departments to drive inspection readiness and support regulatory interactions.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence outcomes.
• Understand when to escalate, when to intervene, and when to let teams move forward.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications

• Bachelors + 17 or Masters + 14 or PhD + 10 years of related experience within the pharmaceutical industry.
• Minimum of eight (8) years building, implementing and/or managing Quality Management Systems within the pharmaceutical industry
• At least five (5) years of experience with Phase 3 and/or commercial product
• At least three (3) years of experience in an outsourced environment
• Successful track record of translation and implementation of requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations (e.g. EU, China, Japan, Australia) and practices.
• Must have excellent verbal, written, interpersonal, organizational and communication skills both internally and externally
• Strong technical understanding and experience in implementing and validating cloud-based (hosted) computer systems
• The ability to perform at executive levels while collaborating with key stakeholders in an exciting, dynamic environment with a high degree of engagement and enthusiasm.
• Ability to make timely and sound quality decisions when faced with complex compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to manage, motivate and influence others with variable workloads and demanding timelines. Prior management experience is required.
• Ability to tactically and strategically execute the day-to-day operations to support Jade’s goals.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs) from scratch.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).