GMP for Mid-Level Management in the Pharmaceutical Industry

Pharmaceutical trainer, consultant, and coach with over 20 years of expertise in GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice). Karen Zimmermann helps pharmaceutical organizations enhance their level of quality and compliance by fostering a quality culture, leading to high-quality products and services.

As the owner of Connectives Learning, she assists passionate pharma professionals and consultants in becoming inspiring trainers, enabling participants to learn easily without them needing to possess all the knowledge themselves. Since 2015, Karen has been active at PCS - Pharmaceutical Consultancy Services as a pharmaceutical trainer, consultant, and coach.

She provides training in areas such as quality culture, human error reduction, train-the-trainer, risk management, batch documentation review, data integrity, GMP for middle management, GDP, and leadership in the pharmaceutical industry.

Additionally, she consults on various GMP/GDP-related projects and has collaborated with a wide range of pharmaceutical companies.

Previously, Karen was Quality Manager at Actavis (now Allergan), where she was responsible for the quality management system according to ISO, GMP, and GDP standards. She served as the Qualified Person for the packaging process and the Responsible Person for the GDP license. With her background in quality management and her passion for developing people and teams, Karen helps organizations reach a higher level of quality and efficiency within the pharmaceutical sector.

Experienced senior consultant with extensive expertise in quality management within the pharmaceutical industry, with a strong focus on GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice).

Jolanda Tijmes has over 20 years of experience in various management and consultancy roles at renowned organizations such as DSM, Patheon, and PCS. Since October 2019, Jolanda has been working as an external senior consultant at PCS - Pharmaceutical Consultancy Services, where she applies her expertise in auditing, change management, and training & development. She assists organizations in optimizing quality processes and enhancing overall quality levels.

Previously, she held leadership positions at DSM, including Global QA Operations Manager and QA Manager, where she was responsible for global quality processes across a network of locations in Europe, North America, and Sydney. At Patheon, she served as Director Quality Affairs, ultimately responsible for the quality and safety of medicinal products delivered under cGMP regulations.

With a background in biotechnology (PhD) and a passion for sustainable quality improvement, Jolanda helps organizations create structure and clarity to implement effective GMP/GDP practices. Her skills in team management, leadership, and coaching contribute to increasing quality and efficiency within the pharmaceutical sector.