Birgit Schulz work email
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Licensed Pharmacist and Quality Assurance Professional with over 25 years of experience in the pharmaceutical and biopharmaceutical industries, spanning multiple countries across Europe and Asia.● Key Skills: Quality Control and Assurance, Pharmaceutical Technology, GMP Consulting, and Technical Project Management.● Leadership: Proven experience managing teams of up to 50 FTEs.● Cross-Functional Expertise: Extensive background in Supply Chain, Regulatory Affairs, Pharma Product Development / IMP, and Pharmacovigilance, with a track record of successfully leading cross-functional projects.● Qualifications: Fullfilling requirements for „ Qualified Person EU “/ „Sachkundige Person “/ „ Fachtechnisch Verantwortliche Person “.● GMP Auditor: Highly qualified and experienced in auditing pharmaceutical sites, raw material suppliers, packaging manufacturers, and other quality organizations.
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Senior Compliance ManagerAlvotech Nov 2023 - Oct 2024Reykjavík, 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. -
Senior Quality Program LeadAlvotech Jul 2021 - Oct 2023Reykjavík, 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.
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Quality Project Manager Region ApacBayer Consumer Care Ag Mar 2017 - Apr 2021Basel 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 -
Head Of QualityP.T. Bayer Indonesia Aug 2016 - Mar 2017Depok• 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. -
Quality Excellence Project ManagerP.T. Bayer Indonesia Jul 2015 - Jul 2016Depok• 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.
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Global Quality ManagerBayer Consumer Care Ag Oct 2010 - Jun 2015Basel 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 processes.• 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.
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Technical Supplier ManagerBayer Consumer Care Ag May 2005 - Sep 2010Basel 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.
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Process TechnologistBayer Bitterfeld Ltd. Sep 2001 - Apr 2005Bitterfeld, 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.
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Head Of Quality Unit, Kontrolleiter AmgSerumwerk Bernburg Ag Sep 1990 - Aug 2001Bernburg, 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.
Birgit Schulz Skills
Birgit Schulz Education Details
Frequently Asked Questions about Birgit Schulz
What is Birgit Schulz's role at the current company?
Birgit Schulz's current role is Championing Quality from Strategy to Execution / Experienced Quality Assurance Leader / Expert in Quality Standards, Compliance and Operations for Pharmaceuticals & Biopharmaceuticals.
What is Birgit Schulz's email address?
Birgit Schulz's email address is bi****@****yer.com
What schools did Birgit Schulz attend?
Birgit Schulz attended The Martin Luther University Of Halle-Wittenberg.
What skills is Birgit Schulz known for?
Birgit Schulz has skills like English, Russian, French, German, Quality Assurance, Contract Manufacturing, Quality Control, Change Control, Gmp, Cross Functional Team Leadership, Quality System, Validation.
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Birgit Schulz
Associate Director Fertilizers At S&P Global, Responsible For Short-Term Fertilizer Forecasts.Greater Hamburg Area1spglobal.com -
Birgit Schulz
Austin, Tx6gmail.com, apple.com, apple.com, aol.com, women.com, dpr.com
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