Director of Quality

Skills Alliance; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Skills Alliance seeks an experienced Quality Director to lead the Quality function at a pharmaceutical manufacturing site focused on Active Pharmaceutical Ingredients (APIs). This senior role owns the Quality Management System, driving GMP compliance and regulatory readiness across clinical and commercial manufacturing activities.

You will provide strategic oversight of QA and QC, manage regulatory inspections and audits, lead deviations, CAPAs and continuous improvement programs, and partner

Qualifications

• Bachelor's degree in Chemistry/Life Sciences; Master's degree preferred.
• Minimum 10 years in pharmaceutical/biotech manufacturing environments.
• Minimum 8 years in Quality Operations, ideally in a CDMO.
• Strong knowledge of cGMP, FDA 21 CFR and ICH guidelines.
• Proven experience leading Quality teams and managing regulatory inspections.
• Experience overseeing API manufacturing quality systems and product release.

Responsibilities

• Provide strategic leadership across QA and QC, driving a robust Quality Management System.
• Ensure compliance with global GMP requirements, FDA regulations, ICH guidelines and applicable regulatory standards.
• Lead regulatory inspections, customer audits and inspection readiness programs.
• Oversee quality risk management, deviations, investigations, CAPAs and continuous improvement initiatives.
• Maintain oversight of batch disposition and the release of API intermediates and finished products.
• Approve validation and qualification strategies, protocols and reports.
• Develop and maintain strong relationships with customers, regulatory authorities and internal stakeholders.
• Oversee Quality Agreements and support regulatory CMC activities, including DMF maintenance.
• Lead, develop and mentor high-performing QA and QC teams.
• Partner with site leadership on strategic projects, capital investments and operational excellence initiatives.

Skills

Leadership

Regulatory governance

GMP compliance

FDA 21 CFR

ICH guidelines

Stakeholder management

Strategic leadership

Mentoring & team development

Education

Bachelor's in Chemistry / Life Sciences

Master's degree (advantageous)

Job description

We are seeking an experienced Quality Director to lead the Quality function at a pharmaceutical manufacturing site specializing in Active Pharmaceutical Ingredients (APIs).

This is a senior leadership position with responsibility for the site's Quality Management System, ensuring the highest standards of GMP compliance, regulatory readiness, product quality and operational excellence across both clinical and commercial manufacturing activities.

Key Responsibilities

• Provide strategic leadership across Quality Assurance and Quality Control, driving a robust and effective Quality Management System.
• Ensure compliance with global GMP requirements, FDA regulations, ICH guidelines and applicable regulatory standards.
• Lead regulatory inspections, customer audits and inspection readiness program's.
• Oversee quality risk management, deviations, investigations, CAPAs and continuous improvement initiatives.
• Maintain oversight of batch disposition and the release of API intermediates and finished products.
• Approve validation and qualification strategies, protocols and reports.
• Develop and maintain strong relationships with customers, regulatory authorities and internal stakeholders.
• Oversee Quality Agreements and support regulatory CMC activities, including DMF maintenance.
• Lead, develop and mentor high-performing QA and QC teams.
• Partner with site leadership on strategic projects, capital investments and operational excellence initiatives.

Requirements

• Bachelor's degree in Chemistry, Life Sciences or a related scientific discipline; a Master's degree is advantageous.
• At least 10 years' experience within pharmaceutical, biotechnology or related manufacturing environments.
• Minimum 8 years' experience in Quality Operations, ideally within a CDMO environment.
• Strong knowledge of cGMP, FDA 21 CFR and ICH guidelines.
• Proven experience leading Quality teams and managing regulatory inspections.
• Experience overseeing API manufacturing quality systems and product release.
• Excellent leadership, communication and stakeholder management skills.
• A strategic, hands-on approach with the ability to drive compliance, organizational development and continuous improvement.