Site Quality Head, Quality Director

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

DESCRIPTION:

At Thermo Fisher Scientific, you'll lead Quality Assurance initiatives that make a meaningful impact on global health. As the Site Quality Head for our Oral Solid Dose CDMO facility, you'll ensure regulatory compliance, drive continuous improvement, and uphold the highest quality standards across manufacturing operations. Working collaboratively with cross-functional teams, you'll provide strategic direction for quality systems while fostering a culture of excellence. You'll apply your expertise to protect product quality, enhance customer satisfaction, and enable our mission of making the world healthier, cleaner and safer.

The Site Quality Head serves as the independent Quality authority on the Site Leadership Team and holds ultimate responsibility for ensuring that all products manufactured, tested, and released from the site meet global regulatory requirements and Thermo Fisher Scientific quality standards. This role is critical in leading and owning the quality strategy, regulatory compliance, and Pharmaceutical Quality System execution for an Oral Solid Dose CDMO manufacturing facility, ensuring consistent delivery of high quality products including tablets, capsules, granules, and soft gel formulations.

How you will make an impact:

Establish and implement a site quality strategy aligned with business objectives and regulatory expectations

Represent Quality on the Site Leadership Team and embed quality principles into site decision making

Promote a proactive quality culture focused on risk management, compliance, and continuous improvement

Ensure full compliance with global regulatory standards including FDA 21 CFR Parts 210 and 211, EU GMP, and ICH guidelines

Maintain continuous inspection readiness and lead regulatory inspections

Provide quality oversight for OSD manufacturing processes

Lead the site Pharmaceutical Quality System

Hold final authority for batch disposition and product release decisions

Serve as the senior quality interface for CDMO clients

Lead and develop the site quality organization

What you will do:

Serve as the primary quality interface with regulatory authorities

Oversee granulation, compression, and coating processes

Manage blend uniformity and content uniformity controls

Supervise dissolution testing and stability programs

Direct cleaning validation and process validation lifecycle

Implement risk-based decision making aligned with ICH Q9 and ICH Q10 quality management principles

Ensure strong data integrity governance aligned with ALCOA plus principles

Exercise authority to halt manufacturing when quality or compliance risk is identified

Support client audits and collaborate with operations and development teams

Build high performing teams and succession pipelines within the quality organization

Monitor and improve key performance metrics including regulatory inspection outcomes, batch quality performance, deviation and CAPA cycle times, and supplier quality performance

REQUIREMENTS:

How you will get here:

Bachelor's or advanced degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field

12 to 15 years of pharmaceutical manufacturing experience including significant leadership roles in quality

Strong knowledge of OSD manufacturing processes, cGMP requirements, and regulatory expectations

Comprehensive understanding of FDA, EMA, and global regulatory requirements

Proven experience leading and developing quality teams in a pharmaceutical manufacturing environment

Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control

Strong understanding of risk management methodologies and quality tools

Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities

Proficiency in root cause analysis and implementation of corrective actions

Expertise in validation, qualification, and computer system compliance

Strong written and verbal communication skills

Ability to collaborate effectively across all organizational levels and with CDMO clients

Experience with quality management software systems

Strong project management and problem-solving capabilities

Travel up to 20% may be required

Experience implementing continuous improvement initiatives in a pharmaceutical manufacturing setting

Multilingual abilities highly valued for international sites