Senior Director, Clinical Quality Assurance

HYBRID (2/3 days in Office)
EXEMPT

COMPANY OVERVIEW

Pretzel Therapeutics is tackling the roots of mitochondrial disease together with the world’s experts in mtDNA and mitochondrial biology plus world-class drug developers.  Our therapeutic targets are chosen based on years of cutting-edge research on mitochondrial function by Pretzel’s founders, and our lead programs are built on a strong foundation of biochemical and pharmacological data.

This is a fantastic career opportunity within an early-stage company dedicated to advancing a new era in Mitochondrial Therapeutics.

POSITION SUMMARY

The Sr. Director, Clinical Quality Assurance, is responsible for establishing and implementing the strategy for the Clinical Quality Assurance (QA) function. This role oversees all Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and Good Pharmacovigilance Practice (GVP) and QA activities by developing and implementing program and/or study level quality plans, proactively identifying critical quality and compliance risks, and establishing effective mitigation strategies to drive excellence in study execution and to minimize regulatory risk.  This individual brings deep expertise in building and scaling GCP, GLP, GCLP, and GVP quality systems.

This leader partners closely with senior management and cross-functional stakeholders to design and implement risk-based, phase-appropriate strategies that ensure Pretzel’s clinical programs comply with global regulations, ICH guidelines, and industry best practices. When applicable, this role also partners with Information Technology on clinical computerized system validation initiatives.

KEY RESPONSIBILITIES

• Lead the Clinical QA Team including employees, contractors, and consultants
• Develop and implement global GCP/GVP/GLP Quality strategies for Phase I – IV clinical studies, including establishment and maintenance of phase appropriate quality systems for drug, devices, and combination products; proactively identify risks and mitigations
• Develop appropriate procedures and documentation to ensure standards, practices, policies and procedures follow applicable laws and regulations
• Build commercial PV in collaboration with the PV function including building and leading PV QA
• Work with cross functional and other quality partners to proactively identify Key Quality and Risk Indicators (KQIs/KRIs) and proactively communicate critical-to-quality risks, and resolutions
• Proactively provide GxP QA support and guidance to Clinical Operations based on analysis and interpretation of GxP regulations to assure best clinical QA practices.
• Able to adapt precedent and develop creative and effective solutions to solve Problems.
• Lead Quality Event investigations, root cause analysis, and relevant CAPA.
• Develop and deliver regulations (e.g., GLP, GCP, CFR Part 11).training to the research and development team. Lead domestic and international audits of sites, documents, databases, vendors, or internal systems.
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks as needed.
• Support investigational new drug applications and related correspondence from global regulatory authorities.
• Develop and oversee appropriate Quality metrics and reporting on the state of Pretzel’s compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.
• Assure global regulations are followed for clinical trial reporting, including submission of adverse events/SAE reporting and all required clinical reports.
• Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes.

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in a scientific discipline is required
• Minimum of 7 years of experience in clinical research area inclusive of, but not limited to, GLP, GCP, GVP QA and compliance to include broad drug experience that spans all clinical phases (Phase I to BLA/NDA)
• Broad understanding of international regulations (e.g., FDA, EMA, MHRA, PMDA) to include GCP Quality for pre-clinical, clinical, and commercial stage work
• In-depth experience implementing and ensuring GCP requirements in clinical trials (e.g., GCP oversight, auditing, global inspection readiness.)
• Proven experience in successfully developing and implementing a risk-based clinical quality assurance program
• Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, quality events, investigations, training, and CAPA
• Working knowledge of the therapeutic area would be beneficial
• Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources, consistently delivers

BENEFITS

All eligible employees receive a generous package that includes: compensation, discretionary bonus, incentive stock options, the opportunity to participate in the Company’s health, dental, vision and 401k plans, life and disability insurance benefits, non-accrual paid time off, company holidays and winter company shut down!

We embrace diversity and do not discriminate based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. Reasonable accommodations will be provided for individuals with disabilities during the application process, interviews, and while performing essential job functions. Contact Human Resources for accommodation requests.

RECRUITMENT

The Human Resources department oversees all recruitment and employment activities for Pretzel. Please note that unsolicited resumes sent to Pretzel by recruiters do not establish any form of relationship between the recruiter/recruiting agency and Pretzel. Submission of unsolicited resumes also does not impose any obligation on Pretzel to pay fees should we choose to hire from those resumes.

We kindly request that candidates, external recruiters and agencies refrain from contacting or directly presenting candidates to our hiring manager or employees.

All applications will be processed on an ongoing basis until the position is filled.

To apply, please send a resume with your full name in the resume title and an email with the title of the position you are applying for to: careers@pretzeltx.com