Birgit Schulz Email & Phone Number

Reykjavík, Capital Region, Iceland

• Managed compliance and quality related processes, including Quality Risk Management (QRM), Quality Management Reviews (QMR), product and market complaints, Annual Product Quality Reviews (APQR)
• Established an optimized process for product complaint management, successfully demonstrating compliance with various health authorities.

Reykjavík, Capital Region, Iceland

• Acted as the sole point of contact for all quality-related aspects of multiple biosimilar products in both development and commercialization phases.
• Monitored and managed quality deliverables, including stability study results, analytical method validations and optimizations, change controls, and quality KPIs.
• Supported and led cross-functional teams to ensure alignment and drive project success.
• Successfully contributed to the launch of Alvotech’s first biosimilar formulation in March 2022, demonstrating effective collaboration and commitment to quality standards.

Basel Area, Switzerland

• Provided corporate quality support for all Consumer Health products marketed in the APAC and Africa regions, encompassing over 300 formulations.
• Ensured quality oversight for Country Quality organizations within the region.
• Led project management for global quality initiatives, driving compliance and best practices across the organization.
• Conducted numerous quality audits as a certified corporate quality auditor

Depok

• Led a team of over 50 employees in driving the continuous improvement of the Quality Management System and enhancing quality performance at the site.
• Managed quality assurance for manufacturing of diverse pharmaceutical products for human health for several markets (Asia, Europe, US), including solid, liquid and ointment forms.
• Continued to be the main Quality contact for the site expansion project, overseeing the process until full implementation.

Depok

• Consulted on upgrading the Quality Management System and optimizing quality-related processes to enhance compliance and efficiency.
• Led preparation efforts for key Health Authority audits, including TGA.
• Served as the Quality Lead on a €29 million site expansion project, ensuring quality standards in all phases of development and execution.

Basel Area, Switzerland

• Provided quality support and oversight across up to 10 manufacturing sites in Europe and North America, with responsibility for Quality Agreements, Deviations/OOS, CAPAs, Change Control, and other quality-related.
• Contributed to key quality initiatives, including site KPI and performance improvement projects, as well as analytical transfer processes.
• Acted as Key Account and Knowledge Manager for Food Supplement production within the Consumer Health Division.
• Led Contract Management as the designated Process Owner within Global Quality Management.
• Conducted quality audits as a certified Bayer auditor, ensuring compliance with regulatory and company standards.
• Provided successful short-term consulting for the GP Grenzach site (10/2013 – 01/2014), focusing on FDA audit preparation and Quality Management System enhancements for sterile facilities.

Basel Area, Switzerland

• Provided technical support for 5-10 manufacturing sites across Europe and Africa, specializing in food supplements and OTC product manufacturing.
• Led technology transfer projects between Bayer sites and external partners, as well as other global initiatives.
• Served as Key Account for Product Supply in New Development Projects within Consumer Care, ensuring seamless integration and support across development stages.

Bitterfeld, Germany

• Elaboration and implementation of a risk-assessment based and cost-efficient validation approach including 40 different qualification/validation subprojects.
• Responsible for technology product transfers and process technology support of routine production (solid forms).
• Leading process improvement/optimization projects.

Bernburg, Germany

• Managed quality assurance for manufacturing of diverse pharmaceutical products for human and animal health, including solid, liquid, ointment, and sterile forms.
• Acted as Qualified Person for batch release and pharmacovigilance, ensuring regulatory compliance and product safety.
• Led a team of 12 employees, fostering a high-performance quality management culture.
• Achieved full implementation of a Quality Management System (QMS) in compliance with GMP and ISO 9001 standards.
• Successfully planned and oversaw the reconstruction and modernization of the analytical laboratory.
• Directed project management for product updates, new product implementations, and launches, driving the company's growth on an international scale.