Head of Quality - Stealth Mode Biotech : Job Details

Position Overview:

The Head of Quality will be responsible for overseeing the quality systems, processes,

and compliance related to this Stealth NewCo's clinical development activities. This role will ensure

the company adheres to stringent regulatory requirements and Good Clinical Practices

(GCP), Good Manufacturing Practices (GMP), and other relevant industry standards.

Key Responsibilities:

 Quality Management System (QMS): Develop, implement, and maintain a

robust QMS across the organization, ensuring it meets all regulatory

requirements and supports efficient operations.

 Regulatory Compliance: Lead efforts to ensure compliance with FDA, EMA,

and other regulatory agencies for all clinical trials, CMC (chemistry,

manufacturing, and controls), and clinical data management.

 Clinical Development Oversight: Provide guidance on quality processes for

clinical trials, ensuring GxP (Good Clinical Practice) compliance across the

clinical programs.

 Vendor and Partner Quality Management: Oversee the quality of external

partners, including CROs, CMOs, and other suppliers, ensuring adherence to

quality standards and performance expectations.

 Audit and Inspections: Prepare for and manage internal and external audits,

regulatory inspections, and vendor assessments. Ensure timely resolution of

findings and corrective actions.

 Risk Management: Lead risk assessments related to product development and

clinical trials, mitigating risks and implementing corrective/preventive actions.

 Continuous Improvement: Drive continuous quality improvements across the

company by identifying gaps and implementing process optimization strategies.

 Leadership and Team Development: Build and mentor a high-performing

quality team, providing training and development to ensure competency and

engagement.

 Cross-functional Collaboration: Collaborate with R&D, Regulatory Affairs,

Clinical Operations, Manufacturing, and other functions to ensure alignment and

compliance in all stages of product development.

 Documentation and Reporting: Oversee the creation and maintenance of

SOPs (Standard Operating Procedures), quality documentation, and compliance

reports.

Qualifications & Experience:

 Education: Bachelor's degree in Life Sciences, Biotechnology, Chemistry, or

related field. Advanced degree (MS/PhD) preferred.

o 10+ years of experience in quality assurance and compliance within the

biotech or pharmaceutical industry, with at least 5 years in a leadership

role.

o Extensive experience in clinical development, particularly in clinical stage

biotech companies.

o Strong understanding of GxP regulations, FDA, EMA, ICH, and other

global regulatory requirements.

o Proven experience managing audits, inspections, and regulatory

submissions.

o Experience with quality oversight of external vendors and CROs/CMOs.

 Skills:

o Leadership experience with the ability to manage and develop a team.

o Strong analytical and problem-solving skills.

o Excellent communication skills, both written and verbal.

o Ability to work in a fast-paced, dynamic, and often ambiguous

environment.

o Familiarity with electronic document management systems (EDMS), LIMS,

and other quality management tools.