Associate Director Quality Assurance - Pharma

Alcott Global; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Alcott Global seeks an Associate Director, Quality Assurance – Pharma, in El Paso, Texas, to provide strategic direction and oversee QA across pharmaceutical manufacturing operations. The role ensures compliance with FDA regulations, EU GMP, ISO 13485, and global standards while driving risk-based decision-making and continuous improvement.

The successful candidate will lead cross-functional teams, support regulatory inspections, and build a high-performing QA organization focused on quality

Qualifications

• 10+ years of QA in pharmaceutical manufacturing.
• 5+ years leading quality teams or site quality operations.
• Strong knowledge of FDA regulations (21 CFR Parts 210/211/820), EU GMP, ISO 13485, cGMP.
• Experience supporting regulatory inspections including FDA inspections and 483s.
• Ability to lead cross-functional teams and drive compliance culture.
• Experience with sterile manufacturing and aseptic operations preferred.
• Lean/Six Sigma, SAP, MS Office, and QMS experience preferred.

Responsibilities

• Lead end-to-end QA oversight across pharmaceutical manufacturing operations, ensuring cGMP and global quality standards.
• Serve as site QA SME for production quality, in-process controls, batch review, and product disposition.
• Oversee Quality Systems, deviations, CAPAs, change controls, investigations, VoE, and corrective actions.
• Lead regulatory readiness and inspections, including FDA inspections and regulatory responses.
• Drive quality risk management with data-driven analysis and trend surveillance.
• Develop and mentor a high-performing QA organization with a strong quality culture.
• Collaborate with Manufacturing, Supply Chain, Engineering, Regulatory Affairs, EHS, R&D and others.

Skills

Quality Assurance

FDA regulations

Regulatory inspections

Lean/Six Sigma

Cross-functional leadership

Tools

SAP

Microsoft Office

Quality Management Systems

Job description

Associate Director, Quality Assurance – Pharma – El Paso, Texas

Alcott Global has been retained by a leading global organization in the pharmaceutical and medical device manufacturing sector. This leadership role is responsible for providing strategic direction and oversight for Quality Assurance across pharmaceutical manufacturing operations, while ensuring compliance with FDA regulations (21 CFR Parts 210, 211, and 820), EU GMP, ISO 13485, and other global quality standards. As a key member of the site Quality Leadership Team, the Associate Director will drive quality strategy, regulatory readiness, risk‑based decision‑making, and continuous improvement initiatives aligned with both global and site objectives.

The role will lead Quality Assurance oversight across pharmaceutical manufacturing processes including formulation, filling, Triton, and Cascade Water Sterilization (CWS), ensuring robust quality systems, contamination control, product disposition, sustainable compliance, and operational excellence. The individual will also work closely with Manufacturing, Supply Chain, Engineering, Regulatory Affairs, EHS, R&D, and other cross‑functional teams to support compliant pharmaceutical manufacturing operations, strengthen quality culture, and enable business objectives.

What we are looking for

The ideal candidates will bring strong experience in pharmaceutical manufacturing, with a proven track record in Quality Assurance, Sterile Manufacturing, Formulation, Filling Operations, Contamination Control, cGMP Compliance, Regulatory Inspections, Risk Management, CAPA, Deviations, Change Control, Root Cause Investigations, Product Disposition, and Quality Systems.

Key Responsibilities

• Lead end‑to‑end Quality Assurance oversight across pharmaceutical manufacturing operations, including formulation, filling, Triton, and Cascade Water Sterilization (CWS), ensuring manufacturing activities are adequately supported, operationally efficient, and fully compliant with cGMP (21 CFR Parts 210/211), QSR (21 CFR Part 820), ISO 13485, EU GMP, and global quality standards.
• Serve as the site Subject Matter Expert (SME) for Pharmaceutical Manufacturing Quality, providing strategic oversight of production quality, in‑process controls, batch record review, product disposition, contamination control strategies, and risk‑based decision‑making while ensuring manufacturing operations remain inspection‑ready.
• Provide strategic oversight of Quality Systems, ensuring effective management of deviations, CAPAs, change controls, complaints, investigations, verification of effectiveness (VoE), and sustainable corrective actions while driving continuous improvement across pharmaceutical manufacturing operations.
• Lead Quality Compliance and Regulatory Readiness by ensuring compliance with FDA, EU GMP, ISO 13485, and global quality requirements, acting as the site QA lead during FDA inspections, regulatory audits, customer audits, and regulatory responses, including support for 483 observations and Warning Letter remediation activities.
• Drive Quality Risk Management and Operational Excellence by leveraging data‑driven analysis, root cause investigations, quality metrics, trend analysis, and quality risk management principles to identify systemic issues, strengthen quality systems, and improve manufacturing performance.
• Build and develop a high‑performing Quality Assurance organization by providing leadership, coaching, and technical mentorship, fostering a culture of accountability, ownership, urgency, execution, continuous learning, and a strong quality mindset while ensuring appropriate capability across pharmaceutical operations and quality systems.
• Drive strategic quality initiatives through effective collaboration with Manufacturing, Supply Chain, Engineering, Regulatory Affairs, EHS, R&D, and cross‑functional stakeholders to support business continuity, validated manufacturing processes, contamination control, supply reliability, and operational excellence.

Candidate Profile

• 10+ years of relevant experience in Quality Assurance within pharmaceutical manufacturing.
• 5+ years of leadership experience managing Quality teams, pharmaceutical manufacturing quality functions, or site‑level quality operations.
• Strong knowledge of FDA regulations (21 CFR Parts 210/211/820), EU GMP, ISO 13485, cGMP, sterile manufacturing, contamination control, Quality Systems, Risk Management, and regulatory inspection requirements.
• Experience supporting regulatory inspections and interactions, including FDA inspections, 483 observations, Warning Letters, customer audits, and regulatory remediation activities.
• Strong ability to lead cross‑functional teams, drive accountability, strengthen compliance culture, and support operational excellence.
• Pharmaceutical manufacturing experience is mandatory, with experience supporting sterile manufacturing and aseptic operations strongly preferred.
• Experience with Lean/Six Sigma methodologies, SAP, Microsoft Office, and enterprise Quality Management Systems is preferred.