Director, Biologics Development Operational Quality (Hybrid)

Job Description

Summary:

The Director Biologics Operational Development Quality is responsible for oversight of development Quality team activities, technical development of personnel and ensuring the quality of deliverables.

The incumbent is responsible for creation, development and maintenance of relationships with CMO Quality managers and professionals as well as internal stakeholders. The incumbent is known for technical expertise and assists with the strategic alignment of group and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement.

The role will be responsible for working with internal and external stakeholders in a matrix environment; Influencing/building/promoting a culture of Quality and to meet business, quality and regulatory objectives.

Key Duties & Responsibilities

• Provide strategic quality and compliance guidance across biologics development, manufacturing, and clinical supply to ensure alignment with global regulatory expectations
• Lead the implementation and continuous improvement of Quality Management Systems (QMS) supporting development and manufacturing operations.
• Establish and oversee risk management frameworks to proactively identify, assess, and mitigate quality and compliance risks across programs.
• Provide quality oversight of internal operations and external partners (e.g., CMOs, CROs), including supplier qualification, performance management, and technical transfer activities.
• Partner with cross-functional stakeholders (e.g., Manufacturing, Regulatory, Technical Development) to support program execution, regulatory submissions, and inspection readiness.
• Drive inspection readiness and lead or support regulatory inspections, audits, and responses to health authority inquiries.
• Oversee key quality processes including batch disposition, deviations, investigations, change control, and CAPA to ensure compliance and consistency.
• Support development and execution of operational and quality strategies aligned with business goals, ensuring transparency into program performance and risks.
• Lead and participate in cross-functional initiatives to improve quality performance, operational efficiency, and continuous improvement outcomes.
• Develop, coach, and lead a high-performing team while fostering a culture of quality, accountability, and operational excellence.

Required Education

• Bachelor’s degree in a scientific or related discipline (or equivalent education and experience).

Required Experience

• Typically requires 10+ years of relevant experience in quality within a regulated biopharmaceutical or biotechnology environment.
• Prior people management or leadership experience

Required Knowledge & Skills

• Strong knowledge of global GxP regulations (e.g., GMP, GCP) and regulatory requirements across biologics development and manufacturing.
• Experience supporting development, manufacturing, and external partner oversight in a regulated environment.
• Demonstrated ability to lead quality strategy, risk management, and continuous improvement initiatives.
• Strong understanding of quality systems, including deviations, change control, investigations, and CAPA
• Experience working in cross-functional, matrixed organizations with the ability to influence and drive alignment
• Excellent communication and stakeholder engagement skills, including interaction with senior leadership and regulatory bodies.
• Ability to apply risk-based decision-making to support operational and strategic priorities

Other Responsibilities

• May include accountability for budget, resource planning, and organizational development within the function.
• Responsible for building and sustaining a strong quality culture aligned with enterprise goals.

#LI-hybrid

Pay Range:

$176,000 - $264,000

Disclosure Statement: