Senior Executive Director, Quality Management System

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Select, implement, manage, and oversee GxP electronic systems, including any associated Purchase Orders and contracts.

• Develop, implement, manage, continuously enhance, and supervise 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.

• Provide guidance and support to GxP process owners in the implementation and optimization of essential functional area processes.

• Establish and refine policies and standard operating procedures to ensure efficient and compliant management of GxP QMS processes.

• Establish, monitor, and report quality metrics for QMS processes, presenting opportunities for improvement at Management Review meetings.

• Implement phase-appropriate, risk-based, fit-for-purpose approaches to QMS processes.

• Ensure compliance of QMS processes with applicable regulatory standards, regulations, and guidelines.

• Stay informed about new regulations, technologies, industry trends, and best practices, applying them as relevant.

• Manage resources effectively to achieve the goals and objectives of the company, department, and functional area.

• Contribute to fostering a positive team-oriented company culture.

• Serve as a coach both as a manager and team member, making quality decisions and acting as Quality Approver when necessary.

• Act as the primary subject matter expert for QMS and the main point of contact for all related matters and issues.

• Review and approve procedures, service provider quality agreements, qualification and onboarding forms, and regulatory filings as appropriate.

• Advocate for continuous improvement and simplification across quality systems.

• Contribute to the development of a robust quality culture within the organization.

• Direct and/or provide annual training for internal staff as required.

• Collaborate closely with Development, Clinical Operations, CMC, and other departments to ensure inspection readiness and support regulatory interactions.

• Prepare KPIs, metrics, and analyses, and present status updates as necessary.

• Provide leadership in preparing for inspections.

• Apply risk-based thinking to identify quality activities that significantly influence outcomes.

• Recognize when to escalate issues, when to intervene, and when to allow teams to proceed independently.

• Offer clear and concise guidance to help teams remain focused, aligned, and ready for inspections.

⛳️ Requirements

• Bachelor’s degree with 17 years, Master’s degree with 14 years, or PhD with 10 years of relevant experience in the pharmaceutical industry.

• A minimum of eight (8) years of experience in 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 products.

• A minimum of three (3) years of experience in an outsourced environment.

• Proven track record of translating and implementing requirements into operational execution.

• Extensive understanding of FDA regulations and practices, ICH guidance, and a strong grasp of global health authority regulations (e.g., EU, China, Japan, Australia) and practices.

• Exceptional 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.

• Ability to perform at executive levels while collaborating with key stakeholders in an exciting, dynamic environment characterized by high engagement and enthusiasm.

• Capability to make timely and sound quality decisions when faced with complex compliance, technical, and regulatory issues. Highly adept at navigating ambiguity and complexity.

• Ability to work with minimal supervision, prioritize tasks to meet deadlines, and manage, motivate, and influence others with varying workloads and demanding timelines. Prior management experience is essential.

• Capacity to tactically and strategically execute daily operations to support the goals of Jade.

• Expertise in reviewing, revising, and authoring Standard Operating Procedures (SOPs) from the ground up.

• A self-starter and a team player who flourishes in a fast-paced, dynamic team environment.

• Proficiency in using SharePoint, Veeva, and Microsoft Office applications is required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

🏝️ Benefits

• This is a remote position; however, 10-20% travel to team and company events will be required.