This innovative, late-phase biotech is seeking a Vice President, Head of Quality to define and lead all quality functions across the organization. This role will ensure compliance and operational excellence from early development through commercialization, supporting the company’s mission to bring advanced biologic therapies to patients globally.
In this role, you will report to the C-Suite and play a pivotal role in quality strategy, regulatory readiness, and team leadership, overseeing all quality functions.
Qualifications:
- Advanced scientific degree (Master’s accepted, PhD preferred) in a relevant life sciences discipline.
- Extensive experience (15+ years) in Quality Assurance within pharmaceutical or biotech organizations, with at least 8 years in executive leadership roles.
- Expertise in biologics development, including large molecule therapeutics and sterile manufacturing.
- Proven record of guiding products through late-stage development and market launch.
- In-depth knowledge of global regulatory standards, including FDA, EMA, and ICH, across GMP, GLP, GCP, and GDP.
- Experience managing and evaluating the performance of external partners such as CDMOs, CROs, and suppliers.
- Strong history of designing, implementing, and scaling Quality Systems to support organizational growth.
Key Responsibilities:
- Develop and implement a comprehensive quality strategy aligned with company goals.
- Build, mentor, and lead a high-performing Quality team, fostering accountability and professional growth.
- Create and maintain flexible Quality processes suitable for all stages of product development, from pre-IND through commercialization.
- Oversee global third-party partners to ensure adherence to quality standards and contractual obligations.
- Lead preparation for regulatory inspections and submissions, proactively addressing issues and mitigating risk.
- Collaborate with cross-functional teams to integrate quality considerations into operational and strategic decisions.
- Manage financial and resource planning for the Quality function, optimizing efficiency and impact.
This is a fully remote role with approximately 20% travel, including international travel and occasional evening meetings to coordinate with global teams. There is a strong preference towards candidates on Pacific time.
