Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges.

Quality Director Sterile Pharmaceutical Manufacturing | GMP | Global Environment

Make an Impact Where Quality Protects Patients

We are seeking an experienced and influential Quality leader to join our organization and take full ownership of Quality Systems and Compliance at a complex, sterile pharmaceutical manufacturing site.

In this highly visible role, you will shape quality strategy, lead large and diverse teams, and partner closely with Operations, Engineering, Supply Chain, and global stakeholders to ensure the highest standards of patient safety, product quality, and regulatory compliance.

You will be expected to role model our 4-I values — Integrity, Intensity, Innovation, and Involvement — embedding a strong quality culture across the site and acting as a trusted leader during both routine operations and regulatory inspections.

Key Responsibilities

Quality Leadership & Compliance

• Ensure full compliance of site operations with EU GMP, US GMP, corporate quality standards, and internal policies.

• Act as the site quality authority during regulatory inspections, audits, and interactions with health authorities.

• Drive alignment between site practices, global procedures, and evolving regulatory expectations.

Quality Management System (QMS)

• Lead, maintain, and continuously improve the Quality Management System (QMS) to support operational excellence.

• Provide oversight of deviations, complaints, OOS, CAPAs, change control, and documentation systems, ensuring data integrity and timely closure.

• Oversee the creation, routing, approval, and issuance of critical GMP documentation supporting all phases of product operations.

• Lead coordination of customer change controls, ensuring approvals in line with quality agreements.

Performance, Risk & Continuous Improvement

• Define, monitor, and analyze Quality KPIs, identifying trends and driving continuous improvement initiatives.

• Apply quality and risk management tools such as FMEA and structured problem-solving methodologies.

• Promote a proactive, risk-based approach to quality across all departments.

People & Organizational Leadership

• Lead and develop large quality organizations (8–10 direct reports, 50 indirect), fostering accountability, engagement, and high performance.

• Ensure effective resource planning, talent development, and succession planning within the Quality function.

• Champion a strong culture of quality, ownership, and continuous improvement across the site.

Cross-Functional & Strategic Contribution

• Collaborate closely with Operations, Engineering, Supply Chain, and customers to ensure compliant and efficient processes.

• Manage the departmental budget, balancing cost efficiency with uncompromised quality standards.

• Contribute to strategic decisions impacting site performance, compliance posture, and long-term capability.

• Provide leadership and oversight for Electronic Execution Systems (documentation, deviations, change control, etc.).

What You Bring

Experience & Expertise

• 15 years of cGMP experience in the pharmaceutical industry, including sterile manufacturing.

• Demonstrated experience leading regulatory inspections (mandatory).

• 10 years in senior leadership roles, ideally within an international or matrixed environment.

• Proven experience working with external regulatory authorities and managing inspections end-to-end.

• Track record of leading and developing large, complex quality teams.

Education & Credentials

• Degree in Biology, Chemistry, Biotechnology, or a related scientific discipline.

• Qualified Person (QP) nomination by AIFA is a strong advantage.

Skills & Capabilities

• Deep expertise in GMP, QMS, data integrity, and quality risk management.

• Strong strategic planning and execution capability for quality initiatives.

• Excellent problem-solving, decision-making, and stakeholder influence skills.

• Ability to operate with confidence, resilience, and clarity in high-pressure regulatory environments.