Dr. Wolfgang Pitsch

Wolfgang brings a combination of scientific knowledge, engineering-oriented thinking and more than two decades of experience in radiopharmaceutical quality and manufacturing.

With a doctorate in organic chemistry and postgraduate education in radiopharmacy, his professional journey began in validation. From there, he progressed through Quality Assurance and Quality Control leadership to become Quality Operations Director and Head of Quality at GE HealthCare's Braunschweig site.

This progression has shaped his understanding of how technical systems, manufacturing processes, regulatory requirements and the people operating them must work together.

From Validation to the Full Facility Lifecycle

Wolfgang's early responsibilities included developing and validating an autoclave plant, validating analytical equipment and establishing a site validation-management system.

Over the following years, his responsibilities expanded to radiopharmaceutical manufacturing, quality systems, batch release, inspections and operational leadership.

His experience now also includes the ongoing GMP decommissioning of the Braunschweig manufacturing site.

Few professional journeys offer such a continuous perspective: from developing and qualifying systems, through years of regulated operation and change, to managing the quality requirements associated with decommissioning.

For Wolfgang, lifecycle thinking is therefore not simply a regulatory concept. It reflects practical experience of what systems must deliver throughout their working life.

Building Quality Systems That Work

Throughout his career, Wolfgang has contributed to major cross-site and international quality-system projects.

He was involved in the development and implementation of TrackWise for deviation management, CAPA and change control, followed by complaint management and preventive maintenance and calibration.

His work included local implementation leadership, global system-development activities, and supporting other sites with quality-system challenges. He also contributed to international complaint-handling activities and quality-system implementation outside Germany.

These experiences reinforced an important principle: implementing a system is not merely a software project. Processes, technical requirements, responsibilities and ways of working must fit together if the system is to deliver lasting improvements.

A Chemist with an Engineering Mindset

Wolfgang approaches complex challenges with scientific curiosity, technical understanding and a preference for practical solutions.

He is interested in what a process or system must actually achieve, which risks need to be controlled and where unnecessary complexity can be avoided.

His background in validation, Quality and operational leadership allows him to challenge both technical and regulatory assumptions.

He believes that compliance and efficiency should reinforce one another. A compliant solution must also be technically sound, workable and sustainable in daily operations.

Regulatory Responsibility and Radiation Protection

Wolfgang has held Qualified Person responsibilities for radiopharmaceuticals since 2007, combining regulatory accountability with direct experience in product release, supplier audits and inspections.

His experience also includes radiation protection responsibilities in radiopharmaceutical manufacturing, supported by specialist education and training.

His involvement in the German Pharmacopoeia's expert group for radiopharmaceuticals provides an additional connection to the development and interpretation of radiopharmaceutical quality standards.

Together, these perspectives help him consider pharmaceutical quality, technical operations and radiation protection as connected requirements rather than isolated disciplines.

What Wolfgang Brings to Qualificiency

At Qualificiency, Wolfgang contributes his experience in chemistry, validation and qualification, pharmaceutical quality systems, regulatory responsibility and technical problem-solving.

He is particularly valuable where Quality, Engineering and Operations intersect, and where decisions require more than simply following a procedure.

His approach reflects a straightforward conviction: the best solutions are those that address the actual risks, meet regulatory expectations and work reliably in practice.