Human Factor is seeking, on behalf of a client, a well-established and growing pharmaceutical company, an experienced and strategic Quality Operations & Compliance Director to lead the organization’s Pharmaceutical Quality Management System (PQMS) and drive excellence in quality, compliance, and operational performance.

About The Role

The Quality Operations & Compliance Director will provide strategic leadership and oversight across Quality Operations, ensuring that pharmaceutical manufacturing activities consistently comply with applicable global regulatory and GMP requirements.

Working closely with Supply Chain, Quality Control, Manufacturing Operations, and Senior Management, the role will be responsible for maintaining a robust and continuously evolving quality framework, ensuring the timely, compliant, and safe release of products to market.

The successful candidate will also act as a key Quality Subject Matter Expert for Health Authority inspections and will lead the organization's approach to inspection readiness, regulatory intelligence, Data Integrity, Quality Risk Management, and third-party quality oversight.

Key Responsibilities

Provide strategic direction and oversight across Quality Operations and all key interfaces supporting commercial pharmaceutical manufacturing
Partner with Supply Chain, QC, and Manufacturing Operations leadership to ensure timely, compliant, and safe product release
Lead, mentor, and develop a strong, collaborative, and high-performing Quality team, fostering professional growth and operational resilience
Drive inspection readiness and act as a primary Quality Subject Matter Expert during local, EMA, and international Health Authority inspections
Establish and maintain proactive regulatory intelligence processes to monitor, interpret, and implement emerging global GMP regulations, guidelines, and industry expectations
Own, govern, maintain, and continuously improve the Pharmaceutical Quality Management System (PQMS) in accordance with local, European, and international Health Authority GMP requirements
Own and continuously mature the Data Integrity Program across all PQMS interfaces, ensuring alignment with ALCOA+ principles and applicable EMA, WHO, FDA, and PIC/S expectations
Lead Quality Operations Management Review activities and present Quality Objectives and Key Quality Performance Indicators to Senior Management
Champion integrated Quality Risk Management and data-driven decision-making to identify systemic risks, improve process efficiency, and minimize compliance risks
Manage Quality relationships and provide oversight of third-party organizations, ensuring external operations comply with internal PQMS expectations, international regulatory requirements, and approved product regulatory filings

Requirements

Bachelor’s and Master’s degree in Chemistry, Chemical Engineering, Pharmacy, Biology, or a related scientific discipline
20+ years of progressive experience in Quality Operations, Quality Compliance, and/or Quality Management within pharmaceutical manufacturing
Deep and proven expertise in the practical implementation of cGMP rules and regulations across European and international markets
Strong knowledge of international Health Authority requirements and inspection frameworks, including US FDA, EMA, ANVISA, COFEPRIS, EAEU, ASEAN, and MFDS
Experience with additional international regulatory frameworks will be considered an advantage
Proven leadership experience with the ability to build, develop, and motivate high-performing Quality teams
Strong track record in Quality Management Systems, inspection readiness, Data Integrity, Quality Risk Management, regulatory compliance, and third-party oversight
Advanced MS Office skills
Proven experience with eQMS, eTMS, eDMS, and ERP systems is required
Excellent strategic, analytical, communication, stakeholder management, and problem-solving skills
Ability to operate effectively in a complex, international, and highly regulated pharmaceutical environment