Industry: Global Biopharmaceutical & Advanced Cell & Gene Therapy Manufacturing
Executive Leadership Team | Reports to: Chief Executive Officer & Board Quality Committee
Location: Boston | Basel | San Diego | Hybrid Executive Structure
About the Organization
We are a global biopharmaceutical innovator specializing in advanced biologics, monoclonal antibodies, precision oncology therapeutics, and next-generation cell & gene therapies. Our global manufacturing network includes high-containment biologics facilities, viral vector production suites, sterile fill-finish operations, and temperature-controlled global distribution channels across 40+ countries.
Operating in one of the most regulated and scientifically complex environments in the world, we maintain strict compliance with the FDA, EMA, MHRA, PMDA, and other international health authorities. Our products impact patients facing life-threatening conditions, where quality, safety, and regulatory precision are non-negotiable.
As our pipeline expands and commercial production scales globally, we are seeking a visionary Chief Quality Officer to lead enterprise-wide quality governance, regulatory excellence, and global compliance strategy.
This is not a quality assurance oversight role. This is a global quality governance and patient-safety mandate.
Job Function
The Chief Quality Officer will architect and oversee the enterprise quality management system (QMS), regulatory compliance frameworks, inspection readiness, product quality governance, and global continuous improvement strategy across R&D, clinical development, manufacturing, and distribution operations.
The CQO will serve as the executive steward of product integrity, regulatory alignment, and patient safety at an international scale.
Essential Duties and Responsibilities
- Define and implement a global quality strategy across development and commercial operations
- Oversee enterprise Quality Management System (QMS) across multi-site biologics facilities
- Ensure regulatory compliance with FDA, EMA, and international authorities
- Lead inspection readiness and represent the organization during global regulatory audits
- Oversee validation, qualification, and product release processes
- Direct pharmacovigilance and post-market surveillance quality alignment
- Implement enterprise-wide CAPA (Corrective and Preventive Action) frameworks
- Establish quality metrics and executive dashboards for Board reporting
- Guide data integrity and electronic quality systems modernization
- Lead cross-functional quality collaboration with R&D, Manufacturing, and Regulatory Affairs
- Manage global quality teams across multiple jurisdictions
- Oversee supplier quality governance and third-party risk controls
- Strengthen the enterprise culture of quality and compliance
Strategic Support
- Advise the CEO and Board on quality risk exposure and regulatory posture
- Support global expansion into new regulated markets
- Guide quality integration during acquisitions and product licensing initiatives
- Align enterprise strategy with evolving regulatory frameworks for cell & gene therapies
- Contribute to ESG commitments related to patient safety and product stewardship
- Strengthen partnerships with global health authorities
Job Qualifications and Requirements
- 18+ years of progressive quality leadership in biopharmaceutical or advanced biologics environments
- 8+ years at the executive level overseeing global quality systems
- Proven experience managing FDA/EMA inspections and regulatory audits
- Deep knowledge of GMP, GCP, and global regulatory compliance frameworks
- Experience in cell & gene therapy manufacturing preferred
- Demonstrated success leading multi-site global quality organizations
- Strong understanding of data integrity and quality system digitalization
- Advanced degree in Life Sciences, Pharmacy, or related field required (PhD, PharmD, or equivalent preferred)
- Executive-level certifications in quality management preferred
Personal Capabilities and Qualifications
- Executive presence with strong regulatory and Board communication skills
- Deep commitment to patient safety and product integrity
- An analytical and systems-thinking mindset
- Decisive leadership in high-stakes regulatory environments
- High ethical standards and governance orientation
- Strong cross-functional influence across global teams
- Resilience under regulatory and operational pressure
- Culture-building leadership style promoting compliance excellence
Working Conditions
- Hybrid executive model with 30–40% global travel
- Frequent engagement with regulatory authorities and inspection bodies
- High-accountability environment tied to compliance and product integrity
- Direct Board Quality Committee reporting responsibilities
- Fast-paced biotech innovation ecosystem
Compensation & Benefits
Total Executive Compensation Package: $330,000 – $420,000 USD
Executive Package Includes:
- Competitive base salary within stated range
- Performance-based annual incentive bonus
- Long-term equity participation and executive stock grants
- Comprehensive executive health and wellness benefits
- Retirement and deferred compensation plans
- Relocation and global mobility assistance
- Executive leadership coaching and advisory programs
- Generous PTO and executive leave structure
Why Join Us
- Lead global quality strategy in advanced biopharmaceutical innovation
- Safeguard patient safety across life-changing therapeutic programs
- Influence regulatory excellence at international scale
- Partner with world-class scientific and executive leadership teams
- Competitive executive compensation aligned with enterprise responsibility
- Opportunity to build one of the most advanced quality governance systems in global biotech
