Quality Assurance – Director

Wilmington PharmaTech; Newark, Northern (DE, KY); Hybrid; USD 140,000 - 220,000; Full time

Job summary

Wilmington PharmaTech is seeking a Quality Assurance Director to oversee all QA functions supporting API development and commercial manufacturing. The role ensures cGMP compliance, global regulatory standards, and a culture of quality.

The Director provides strategic leadership, maintains inspection readiness, and partners with Manufacturing, Regulatory, and R&D to drive continuous improvement and operational excellence across the organization. Reports to senior leadership.

Qualifications

• Bachelor’s degree or higher in Chemistry or Life Sciences.
• 5+ years QA experience in pharmaceutical manufacturing or CDMO.
• Direct leadership at management or director level.
• Extensive hands-on experience with cGMP regulations and FDA inspections.

Responsibilities

• Lead and oversee the Quality Management System (QMS) ensuring regulatory compliance across development and commercial programs.
• Maintain inspection readiness and lead regulatory inspections, customer audits, and third-party quality assessments.
• Provide quality oversight for batch records, disposition, deviations, investigations, CAPA, and change controls.
• Apply risk management principles to support development, scale-up, and manufacturing activities.
• Collaborate with Manufacturing, Technical Operations, Supply Chain, and R&D to integrate quality into operations.

Skills

Quality Assurance

Leadership

Cross-functional collaboration

Regulatory compliance

cGMP

Education

Bachelor's degree or higher in Chemistry or Life Sciences

Job description

Wilmington PharmaTech (WPT) is seeking an accomplished Quality Assurance Director to lead and manage all Quality Assurance functions supporting API development and commercial manufacturing operations. This role is accountable for ensuring compliance with cGMP regulations, global regulatory standards, and internal quality systems while supporting business growth and operational excellence. The Quality Assurance Director will provide strategic quality leadership, ensure inspection readiness, and partner cross-functionally to drive a strong culture of quality and continuous improvement across the organization. This position reports directly to senior executive leadership.

Responsibilities

The Role

01

Quality Management System & Compliance Oversight

Quality System Leadership: Direct and oversee the Quality Management System (QMS), ensuring compliance with FDA, EMA, ICH, and other applicable global regulatory requirements.

Policy & SOP Governance: Author, review, approve, and maintain quality policies, procedures, and documentation governing GMP operations, ensuring consistent application across development and commercial programs.

Inspection Readiness: Maintain a continuous state of regulatory inspection readiness and lead all regulatory inspections, customer audits, and third-party quality assessments.

Quality Culture: Promote and reinforce a culture of quality, compliance, and accountability across all functional areas.

02

Operational Quality & GMP Execution

Batch Record Review & Disposition: Provide quality oversight for manufacturing and testing activities, including review and approval of batch records and final product disposition.

Deviation & Investigation Management: Ensure timely investigation of deviations, OOS/OOT results, complaints, and quality events, with effective root cause analysis and sustainable CAPA implementation.

Change Control Oversight: Lead quality review and approval of change controls, evaluating regulatory impact and ensuring changes are implemented in a controlled and compliant manner.

Risk Management: Apply quality risk management principles to support development, scale-up, and commercial manufacturing activities.

03

Cross-Functional Leadership & Continuous Improvement

Business Partnership: Collaborate closely with Manufacturing, Technical Operations, Supply Chain, and R&D to ensure quality is integrated into operational and strategic decision-making.

Metrics & Performance Monitoring: Establish, track, and report key quality metrics to assess system effectiveness and drive continuous improvement initiatives.

Process Optimization: Identify and implement opportunities to improve quality processes, enhance compliance efficiency, and support scalable organizational growth.

KEY REQUIREMENTS

The Candidate

Education: Bachelor's degree or higher in Chemistry, Life Sciences, or a related scientific discipline; an advanced degree is preferred

Experience: 5+ years of Quality Assurance experience within pharmaceutical manufacturing, API, or CDMO environments, including demonstrated leadership at the management or director level.

Regulatory Expertise: Extensive hands-on experience with cGMP regulations and direct leadership of FDA and international regulatory inspections.

Communication: Exceptional written and verbal communication