Senior Director Quality

Fraser Dove International; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

Fraser Dove International, a global biopharmaceutical CDMO, is seeking a strategic Senior Director, Site Quality Head to lead QA and QC across the site, ensuring cGMP compliance and inspection readiness.

You will build and develop a high-performing quality organization, partner with regulatory bodies and clients, and drive continuous improvement in quality systems, deviation management, CAPAs, change control, and data integrity.

Qualifications

• Extensive senior quality leadership experience in a CDMO or external QA role.
• 8+ years in a pharmaceutical manufacturing environment, biologics preferred.
• Deep knowledge of cGMP regulations and FDA inspection history.

Responsibilities

• Lead QA and QC activities across the site, including analytical and microbiology.
• Maintain final accountability for GMP compliance and inspection outcomes.
• Drive quality systems, deviation management, CAPAs, change control, and data integrity.
• Partner with global stakeholders to ensure consistent quality standards.
• Operate as a key member of site leadership, guiding strategic planning.
• Coach and develop a multi-disciplinary quality team.
• Collaborate with regulators and clients for audits and growth.

Skills

Quality leadership

GMP compliance

Regulatory inspections

Stakeholder management

Quality systems

People leadership

cGMP knowledge

Education

BSc in a scientific discipline

Job description

Do you want to lead site-wide quality strategy in a highly regulated biopharmaceutical manufacturing environment?

Are you ready to take full accountability for GMP compliance and inspection readiness?

Do you enjoy building high-performing teams while driving quality, safety, and operational excellence?

Fraser Dove International is partnering exclusively with a leading CDMO. Operating in globally, they are committed to delivering high-quality biologics through compliant, efficient, and patient-focused operations.

Our client is seeking a strategic and hands-on leader to lead site-wide Quality Assurance and Quality Control, ensuring robust systems, regulatory compliance, and continuous improvement.

Your objectives:

As the Senior Director, Site Quality Head, you will be measured against the following objectives:

• Ensure full site compliance with current Good Manufacturing Practice standards, maintaining continuous inspection readiness.
• Define and execute a site-wide quality strategy aligned with organizational growth, operational excellence, and regulatory expectations.
• Build and develop a high-performing quality organization, improving capability, engagement, and performance across QA and QC functions.

What you will do:

As the Senior Director, Site Quality Head, your duties and responsibilities will include:

• Lead and oversee all Quality Assurance and Quality Control activities across the site, including analytical and microbiology functions.
• Hold final accountability for GMP compliance, quality systems, and regulatory inspection outcomes.
• Ensure effective implementation and continuous improvement of quality systems, including deviation management, CAPAs, change control, and data integrity.
• Partner with global quality and cross-functional stakeholders to ensure alignment and consistent application of quality standards.
• Act as a key member of the site leadership team, contributing to strategic planning and operational decision-making.
• Lead, coach, and develop a multi-disciplinary team, driving a culture of quality, accountability, and continuous improvement.
• Collaborate with internal and external stakeholders, including regulatory bodies and clients, to support audits, inspections, and business growth.

What you will bring:

These are the skills and experience you will need to succeed as the Senior Director, Site Quality Head:

• Must have extensive experience in a senior quality leadership role within a CDMO, or in an external quality role.
• 8+ years' experience within a pharmaceutical manufacturing environment, with a strong preference for hands on biologic drug substance experience.
• Deep knowledge of cGMP regulations, including 21 CFR Parts 210 and 211.
• Proven track record of leading regulatory inspections, including FDA audits.
• Strong experience developing and executing quality strategy within a complex, regulated environment.
• Demonstrated ability to influence senior stakeholders and operate effectively within a leadership team.
• Excellent people leadership, coaching, and team development skills.
• BSc in a scientific discipline.

Got what it takes?

Please Note:

• This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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