Jade Biosciences

Jade Biosciences

Senior/Executive Director, Quality Management System

Boston; Chicago; Remote; San Francisco; Seattle · Director

Sponsorship not specified$10k-$20kDetected 25 days ago
ExcelFDA RegulatoryAnimal StudiesLeadershipCommunicationProblem SolvingMentoringMicrosoft OfficeSharePointGxP

About the role

  • The ideal candidate brings hands-on expertise in creating and maintaining a GxP QMS, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Responsibilities

  • Select, implement, manage, and oversee GxP electronic systems including any associated Purchase Orders and contracts.
  • Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes
  • Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes
  • 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 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.

Requirements

  • Bachelors + 17 or Masters + 14 or PhD + 10 years of related experience 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.
  • 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.
  • Prior management experience is required.
  • Minimum of eight (8) years building, implementing and/or managing Quality Management Systems within the pharmaceutical industry
  • 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.
  • 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.
  • A self-starter and a team player who thrives in a fast-paced dynamic team environment.

Compensation

  • 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
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This listing is sourced directly from Jade Biosciences's careers page and normalized into a canonical job model.