BIO
Stefan Zietze
Executive Director, Head QP & Quality Mgt -Safety & Logistics
Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.
Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.
Our multi-disciplinary early phase approach accelerates the path to proof of concept by integrating diverse expertise to optimize study design, generate robust clinical evidence, and reduce gaps between development phases.
We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance. We design patient-informed protocols that remove participation barriers, accelerate enrollment, and increase the likelihood of successful drug launches.
Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, creating customized pathways to maximize global market reach throughout your product's lifecycle.
We enhance your product's value story through post-approval studies and holistic lifecycle management services that satisfy regulators and payers while building stakeholder trust and maximizing your drug's market impact throughout its entire lifecycle.
We bring together experienced cross-functional experts to implement best practices, process simplifications, and technology standardization that accelerate timelines and improve quality.
Get the personal, responsive, and committed approach of a small CRO, with all the benefits of a large CRO, to help you develop life-changing treatments for patients.

Clinical Trialblazers
Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life.
Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.
Our team delivers high-quality clinical trials through forward-thinking medical expertise across multiple indications by combining strategic insight with operational excellence to support programs of all sizes.
Our infectious disease and vaccines cro services help treat and prevent life-threatening illnesses. Learn how our team of experts can aid in any complex trial.
Discover our inflammation and immunology CRO services. We bring agile support and a unique MOA-driven model to inflammation and immunology.
Parexel is a leading Oncology CRO with more than 80 ex-agency regulators and nearly 2,500 sites globally. Learn more about our oncology indications.
As a leading neuroscience CRO, we leverage global site relationships, specialized resources, and indication-specific expertise to accelerate breakthroughs in neurological and psychiatric treatments for patients worldwide.
Our experts help you stay at the forefront of the industry — and ahead of change.

Optimizing the clinical research workforce: An industry analysis by Parexel
At the heart of Parexel sits the world’s most unique insight-generation engine: our people.
Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions.
Clinical trials provide patients with access to innovative investigational treatments that advance medical research. Participation requires careful consideration that weighs both the benefits and risks.

Patient Stories
Clinical study participation represents a deeply personal decision with potentially far-reaching impact, as evidenced by these inspiring individual stories that highlight both the life-changing potential for participants and the broader advancement of healthcare for all.
Want to collaborate with us to offer clinical trials at your site? We would welcome the opportunity to discuss.

Enabling successful sites
Our Enabling Successful Sites thought leadership series pairs site representatives with clinical operations experts to identify root causes of investigative site challenges and develop collaborative solutions.
We are one of the largest CROs in the world, speeding life-changing medicine to market by engaging patients With Heart™. Learn about who we are, what we do, and what we believe.
With decades of biopharmaceutical leadership experience and a deep dedication to patients, our executive team drives us forward in delivering better trials, faster.
Find key information on our policies, strategies, pay data, and more.
Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.
Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.
Our multi-disciplinary early phase approach accelerates the path to proof of concept by integrating diverse expertise to optimize study design, generate robust clinical evidence, and reduce gaps between development phases.
We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance. We design patient-informed protocols that remove participation barriers, accelerate enrollment, and increase the likelihood of successful drug launches.
Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, creating customized pathways to maximize global market reach throughout your product's lifecycle.
We enhance your product's value story through post-approval studies and holistic lifecycle management services that satisfy regulators and payers while building stakeholder trust and maximizing your drug's market impact throughout its entire lifecycle.
We bring together experienced cross-functional experts to implement best practices, process simplifications, and technology standardization that accelerate timelines and improve quality.
Get the personal, responsive, and committed approach of a small CRO, with all the benefits of a large CRO, to help you develop life-changing treatments for patients.

Clinical Trialblazers
Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life.
Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.
Our team delivers high-quality clinical trials through forward-thinking medical expertise across multiple indications by combining strategic insight with operational excellence to support programs of all sizes.
Our infectious disease and vaccines cro services help treat and prevent life-threatening illnesses. Learn how our team of experts can aid in any complex trial.
Discover our inflammation and immunology CRO services. We bring agile support and a unique MOA-driven model to inflammation and immunology.
Parexel is a leading Oncology CRO with more than 80 ex-agency regulators and nearly 2,500 sites globally. Learn more about our oncology indications.
As a leading neuroscience CRO, we leverage global site relationships, specialized resources, and indication-specific expertise to accelerate breakthroughs in neurological and psychiatric treatments for patients worldwide.
Our experts help you stay at the forefront of the industry — and ahead of change.

Optimizing the clinical research workforce: An industry analysis by Parexel
At the heart of Parexel sits the world’s most unique insight-generation engine: our people.
Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions.
Clinical trials provide patients with access to innovative investigational treatments that advance medical research. Participation requires careful consideration that weighs both the benefits and risks.

Patient Stories
Clinical study participation represents a deeply personal decision with potentially far-reaching impact, as evidenced by these inspiring individual stories that highlight both the life-changing potential for participants and the broader advancement of healthcare for all.
Want to collaborate with us to offer clinical trials at your site? We would welcome the opportunity to discuss.

Enabling successful sites
Our Enabling Successful Sites thought leadership series pairs site representatives with clinical operations experts to identify root causes of investigative site challenges and develop collaborative solutions.
We are one of the largest CROs in the world, speeding life-changing medicine to market by engaging patients With Heart™. Learn about who we are, what we do, and what we believe.
With decades of biopharmaceutical leadership experience and a deep dedication to patients, our executive team drives us forward in delivering better trials, faster.
Find key information on our policies, strategies, pay data, and more.
As a Registered Pharmacist Stefan is passionate about Drug Products and their optimal application at patients in need. Predominantly, in the next 10 years biopharma innovation will be driven by the product classes coming out of the exciting field of Cell and Gene Therapy (CAGT). Stefan is a critical thinker and identifies areas of risk in global supply projects highly efficiently with a clear solution-orientation for sponsors and never loosing focus of protecting the receiving patients.
Work Experience
Stefan has started his career in biopharmaceutical pre-clinical product development and manufacturing in the Quality Control unit in a highly innovative CDMO-environment, understanding very soon that only excellent science and reliable technological solutions can keep you successful in this highly competitive market. After 10 years he has moved to the global commercial production scale, extending his knowledge to classical drug product classes, and learning about areas like Indirect Quality Control and Quality System Management. In 2012 he also became Qualified Person supporting a production site managing 150 different SKUs for more than 180 different markets. During this time Stefan could master his Six Sigma Green Belt and adopt methodologies of the ‘Agile Transformation’ tool box. In 2018, Stefan then moved into the exciting field of Clinical Research and Clinical Trial Supplies and Laboratory Sample Logistics applying his knowledge to streamline the Logistics Quality Management team and to help grow the Parexel CTS&L-business. In 2023, his areas of responsibility were extended to the Parexel Safety business unit. Within CAGT, his current interests and commitments lie in finding logistical solutions for CAGT IMPs that are compliant with the multiple regional manufacturing, import/export and distribution regulations and that allow a seamless product release to deliver the products on-time and in-full to the patients in need.