Jade Biosciences

Jade Biosciences

Executive Director, Clinical Quality Assurance

Boston; Remote; San Francisco; Seattle · Director

Sponsorship not specified$265k-$300kDetected 25 days ago
GCPExcelClinical TrialsFDA RegulatoryPharmacovigilanceAnimal StudiesLeadershipCommunicationProblem SolvingMentoringOrganizational SkillsMicrosoft OfficeSharePointGxP

About the role

  • The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, 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

  • Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
  • Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
  • Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
  • Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
  • Identify and assess compliance risk and develop and implement risk mitigation measures.Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
  • 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, and other functions/departments to drive inspection readiness and support regulatory interactions.
  • Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry.

Requirements

  • Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.
  • Successful track record of translation and implementation of clinical requirements into operational execution.
  • A successful track record of working with service providers and CROs.
  • Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations.
  • Highly skilled in the ability to work with ambiguity and complexity.
  • Knowledge of Quality Management Systems
  • Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
  • Strong organizational skills and the ability to participate effectively cross-functionally.
  • Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others.
  • Prior management experience is required.
  • Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
  • Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
  • Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities.
  • experience in building, implementing and managing quality systems in the pharmaceutical industry.
  • Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
  • A self-starter and a team player who thrives in a fast-paced dynamic team environment.
  • Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.

Compensation

  • The anticipated salary range for candidates for this role is $265,000 - $300,000.
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