Senior Director Quality

Fraser Dove International; North Carolina; On-site; USD 190,000 - 270,000; Full time

Job summary

Fraser Dove International is seeking a strategic Senior Director, Site Quality Head to lead end-to-end QA and QC across the site in a regulated biopharmaceutical manufacturing environment.

You will own GMP compliance, drive quality systems, oversee analytics and microbiology, and partner with global quality and cross-functional teams to prepare for regulatory inspections and continual improvement.

Qualifications

• 8+ years in pharmaceutical manufacturing, with hands-on biologics experience.
• In-depth knowledge of cGMP regulations including 21 CFR Parts 210 and 211.
• Proven track record leading regulatory inspections (FDA audits).
• Strong leadership, coaching, and team development abilities.

Responsibilities

• Lead QA and QC activities across site, including analytics and microbiology.
• Hold final accountability for GMP compliance and regulatory results.
• Drive continuous improvement of quality systems (CAPAs, deviations, change control).
• Collaborate with global quality and cross-functional stakeholders.
• Serve on site leadership team guiding strategic decisions.
• Develop and coach a multi-disciplinary QA/QC team.

Skills

CDMO leadership

Pharma manufacturing

cGMP knowledge

FDA inspections

Stakeholder management

People leadership

Biologic drug substance

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, which must include 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.
• If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.