Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

THE OPPORTUNITY

Praxis is seeking a highly experienced, motivated, and strategic Quality leader to join our team as Senior Director, Quality CMC. This individual will lead end-to-end quality oversight for drug development programs from Phase 1 through commercialization, filing, approval, launch, and lifecycle management. This person is accountable for setting and executing Quality strategies, establishing product quality standards, and ensuring alignment with global regulatory expectations across internal functions and external partners, including CMOs and CTLs. This person will work cross-functionally with CMC, regulatory affairs, development, and commercial teams to support Quality by Design (QbD), inspection readiness, and robust supply chain operations. This leader will also provide strategic direction on quality systems health, risk mitigation, and benchmarking to ensure Praxis maintains industry-leading compliance and performance standards throughout the product lifecycle.

QUALIFICATIONS AND KEY SUCCESS FACTORS

• Advanced degree in a scientific or technical discipline preferred; bachelor’s degree required.
• Minimum of 15 years of progressive experience in the pharmaceutical or biotech industry, including late-stage development, commercialization, and lifecycle management.
• Deep expertise in drug substance (DS) and drug product (DP) manufacturing, including process validation, specification setting, and control strategy development.
• Proven leadership in cross-functional matrixed environments, with at least 5 years of direct people management and strategic program leadership.
• Strong command of global GMP regulations and guidances (FDA, EMA, ICH Q7/Q8/Q9/Q10/Q11, 21 CFR 211, Part 11), with direct experience in regulatory submissions and inspections (e.g., NDA).
• Demonstrated success in quality oversight of CDMOs and CTLs, including auditing, vetting, and managing ongoing performance.
• In-depth knowledge of quality systems and compliance frameworks, including change control, deviation/CAPA, and data integrity.
• Track record of driving quality strategy, continuous improvement, and risk-based decision-making in complex development and manufacturing programs.
• Excellent judgment, critical thinking, and communication skills, with the ability to influence across scientific, operational, and executive stakeholders.
• High integrity and ability to foster collaboration and accountability across internal and external partners to support business and compliance goals.
  The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Lead the development and execution of global Quality strategies for Praxis products across clinical and commercial phases.
• Serve as the senior Quality representative on CMC governance teams, ensuring proactive risk identification, resolution, and compliance alignment with global regulatory expectations.
• Drive quality oversight of external partners (CDMOs, CTLs), ensuring performance metrics, audits, and remediation plans are effectively managed.
• Ensure product specifications, control strategies, validation protocols, and analytical methods meet phase-appropriate regulatory and Praxis quality standards.
• Direct product disposition activities for clinical and commercial batches, including resolution of deviations, discrepancies, and batch record reviews.
• Provide leadership and strategic input during technology transfers, process validation, and new product introduction to support global readiness and compliance.
• Ensure readiness for and participate in regulatory inspections and pre-approval inspections (PAIs), serving as Quality lead with Health Authorities as needed.
• Oversee the implementation and continuous improvement of phase-appropriate Quality Systems (deviations, CAPA, change control, complaint handling, data integrity).
• Support preparation, review, and approval of CMC sections in global regulatory filings (IND, NDA) and contribute to responses to Health Authority queries.
• Build and maintain a robust quality framework that integrates QbD, lifecycle management, and best practices in manufacturing science.
• Guide cross-functional teams in interpreting and applying current and emerging regulatory guidance across clinical development and commercial operations.
• Develop, mentor, and align internal Quality team members and cross-functional QA support resources to meet organizational and program-level goals.