Executive Director, Clinical Quality Assurance

Wave Life Sciences • Lexington, MA

5d

About The Position

The Executive Director, Clinical Quality Assurance provides strategic leadership, direction and hands on support for clinical quality assurance operations, ensuring compliance with applicable GCP, GVP and GLP regulations as well as any additional applicable regulatory requirements. They are responsible for driving continuous improvement of Good Clinical Practices (GCPs).

This role partners closely with GMP Quality Assurance and Discovery and Development senior leaders and stakeholders to develop, implement, and continuously improve global and local GLP/GCP quality strategies that align with Wave program pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.

This role reports to the Vice President, Regulatory and Policy.

Requirements

• BSc in a scientific discipline; advanced degree preferred
• 16+ years industry experience working within an organization conducting clinical development
• Tactical and strategic clinical quality assurance experience required
• 10+ years of leadership experience; strong leadership presence and effective decision making required
• Knowledgeable in GCP requirements for multiple jurisdictions, including US and EU
• Strong investigational and change management skills
• Excellent verbal and written communication skills
• Ability to effectively communicate sound Quality advice cross-functionally, based on regulations and business needs
• Strong organization skills with the ability to effectively multi-task and prioritize
• Ability to adapt to changing business needs and meet timelines within a fast-paced environment
• Self-motivated with sound judgement and problem-solving skills
• Knowledge of GxP requirements and sound judgement for the principles of GDP

Nice To Haves

• Specific experience in sterile injectables in clinical development is desirable

Responsibilities

• Develop, implement, and ensure continuous improvement of the clinical quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company policies
• Establish and maintain robust clinical quality standards
• Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents
• Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders
• Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations.
• This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation
• Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities
• Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
• Build and maintain effective relationships with internal and external stakeholders
• Drive a culture of continuous improvement in clinical quality assurance
• Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance
• Build a fit-for-purpose clinical quality assurance team, responsible for the execution and sustainability of GCP across the R&D clinical trial/study portfolio
• Manage oversight of vendors including but not limited to Laboratories, CMOs, and depots, ensuring the establishment of a program for vendor qualification and audit of GxP Development vendors
• Develop and manage the GLP/GCP vendor and site audit plan
• Advance the strategy and manage inspections for GxP Development to ensure that all phases of Regulatory Health Authority are handled consistently and proactively
• Serve as the primary point of contact for Regulatory Health Authority inspections (e.g. Site/Sponsor inspections). Coordinate the internal personnel and documentation necessary to support the Site/Sponsor inspection
• Leads, drives, facilitates and/or supports training, SOP development, remediation, and prevention activities, as needed
• Where appropriate and required, collaborate with GMP Quality and other GxP groups

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program

What This Job Offers

• Job Type: Full-time
• Career Level: Director