THE OPPORTUNITY

The key activity of the role is providing expertise and guidance regarding applicable Good Clinical Practice regulatory requirements and conduct of clinical studies.

The Head, Clinical Quality will utilize a risk-based and phase-appropriate strategy to prioritize GCP quality support for clinical trial activities, identify and escalate compliance issues when appropriate, enable proactive decision making, and support the development and execution of effective and comprehensive action plans to address quality risks and issues. In addition, the Head, Clinical Quality will partner with Clinical Operations, Clinical Development, Regulatory, Pharmacovigilance and other key functions to enable transparency and escalation of quality matters.

This role is responsible for management and operational oversight of Quality Event activities which include deviations, corrective/preventive actions and effectiveness checks within Clinical R&D.

This role will actively contribute to the development, maintenance, and implementation of GCP-related policies, SOPs and other procedural documentation. This role will participate in the management of systems and training relevant to the administration of the Clinical QMS in support of regulatory requirements for application in drug development and clinical trial execution. This position reports to the Global Head, Regulatory Affairs and Clinical Quality.

THE RESPONSIBILITIES

• Participate and proactively provide GXP QA support and guidance in the implementation of GXP compliant procedures and operations to ensure a robust quality management system for the conduct and maintenance of clinical studies
• Develop and implement process improvements to internal programs as indicated by issue management, audit observations, new regulations, guidance documents, and industry standards. Assist cross-functional teams as necessary with the development, review and implementation of SOPs
• Lead Inspection Preparation and support Inspection Readiness activities. Drives strategies for Preparation, Support and Follow-up activities for Inspection Readiness
• Manage the resolution of compliance issues (e.g. CAPAs) identified at clinical vendors and clinical sites and provide assessment of the impact of any deficiencies. Assist teams in the development of CAPA plans and investigations in response to quality issues, audits, and inspections. Lead/chair the clinical portion of Quality Management Review
• Lead Quality Event Management activities related to the investigation, root cause analysis and development of corrective action/ preventive action plans within Clinical R&D.
• Collaborate with stakeholders in conducting ongoing risk assessments of clinical study activity to identify priority studies, compliance metrics for tracking, high-risk service providers, and key Clinical QA activities (i.e., protocol review, service provider risk mitigations, inspection readiness)
• Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct. Conduct impact assessments of new regulations, guidances, and potential trends that may impact Clinical R&D.
• Reviews and analyzes key Performance Indicator data and trends within organization as well as external assessments.
• Analyzes risk and proposes remedial, corrective and /or preventive actions

REQUIRED QUALIFICATIONS

• Bachelor’s degree in the Life Sciences with 10+ years in pharmaceutical or biotech drug development. Advanced degree preferred. Minimum 10 years of experience in Clinical QA.
• Demonstrated experience working with Clinical Trial teams
• Extensive experience with global clinical trial conduct, knowledge and understanding of ICH E6 GCP Guidelines, FDA Regulations and EU Requirements
• Previous experience supporting Regulatory Authority Inspections
• Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team

PREFERRED REQUIREMENTS

• Global GCP regulations (US/EU etc.); ICHE6, 21 CFR Part 50, 54, 56, 312, 314, and high-level knowledge of 21 CFR Part 11 and International equivalents as necessary
• Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
• Risk management principles and process, change management
• Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment
• Excellent communication skills and a proven track record. A strong team player with great interpersonal and written communication skills
• Demonstrated adaptability, flexibility, independence and resourcefulness
• Influencing/building/promoting a culture of Quality and Excellence

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.