Head of Quality

Overview

Bora Pharmaceuticals is a CDMO specializing in formulation development, clinical and commercial manufacturing, and packaging of complex pharmaceutical products. The site leadership team requires a strategic Quality leader to develop, implement, and oversee a comprehensive Quality Management Strategy aligned with corporate policies, client expectations, and global regulatory requirements to ensure products are safe, effective, and compliant with CGMP/GxP standards.

• Provide strategic leadership and accountability for the site Quality Management System (QMS), ensuring compliance with global policies, procedures, CGMP/GxP standards, and applicable regulatory requirements across the U.S. and international markets.
• Partner with the Site Leadership Team (SLT) to sustain a proactive culture of quality, escalate compliance risks, and drive timely, effective resolution of quality issues.
• Lead and oversee regulatory inspections and audits, ensuring inspection readiness, effective agency interactions, and timely, compliant responses to observations.
• Direct core Quality functions, including batch record review, material and product disposition, deviations and change control, document control, QC, QA oversight of all GMP functions including validation, quality engineering, and facility activities.
• Provide leadership to ensure uninterrupted support for successful product transfers through robust quality oversight and operational excellence.
• Serve as the senior Quality leader supporting development initiatives and phased clinical programs, ensuring appropriate compliance throughout product development activities.
• Lead the Quality organization in achieving operational and strategic objectives, including budget planning and management, workforce planning, project execution, and organizational effectiveness.
• Build, mentor, and develop a high-performing Quality organization that operates as a trusted, collaborative business partner, while driving talent development, succession planning, and employee growth.
• Establish clear, consistent, and effective communication across the Quality organization and with cross-functional stakeholders to ensure alignment on priorities, risks, and business objectives.
• Perform additional responsibilities and strategic initiatives as assigned.

• 10+ years of progressive experience within GMP-regulated pharmaceutical and/or combination drug-device manufacturing environments.
• Strong working knowledge of global regulatory requirements and quality standards, including US FDA, EMA, PIC/S, and ICH guidelines.
• 5+ years of senior leadership experience driving Quality strategy, operational excellence, compliance initiatives, and continuous improvement programs.
• Proven ability to build and sustain a transparent, collaborative, and quality-focused culture that promotes accountability, engagement, and operational performance.
• Demonstrated experience leading cross-functional teams and influencing organizational change within complex regulated environments.
• Prior experience within a CDMO environment is strongly preferred.
• Strong knowledge of pharmaceutical manufacturing operations, including Oral Solid Dose (OSD) processes and associated quality requirements.
• Demonstrated success in leading regulatory inspections, audits, and remediation activities with global health authorities.
• Exceptional written and verbal communication skills, with the ability to influence stakeholders and communicate complex quality and compliance matters clearly and effectively.
• Proven ability to lead, mentor, and support teams through crisis management, organizational transformation, cultural change, and business growth initiatives.
• Highly adaptable and resilient, with the ability to perform effectively in fast-paced, high-pressure environments while maintaining focus on priorities and outcomes.
• Strong leadership capability with the ability to empower teams, identify high-potential talent, and drive employee development and succession planning.
• Results-oriented leadership with strong analytical and problem-solving skills focused on continuous improvement and operational excellence.
• Skilled at building…