Director of Quality and Medical Staff

7 days ago

King of Prussia PA, United States CSL Behring Full time

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. You will report to the Senior Director of Clinical Portfolio Execution.

You will establish and manage standards and processes for main study operations activities (e.g., clinical trial support, clinops human biological sample management).
Facilitate global resourcing for clinical portfolio execution roles to support the Head, CPE in ensuring appropriate and resource allocation aligned with project priorities. In collaboration with Business Operations, includes demand planning and utilization across all programs. Ensure there is a communication strategy laterally and vertically for resource management and utilization.
Utilize lessons learned from prior study conduct, site visits, audits, and inspections to develop and implement process improvements. Manage framework/standardized tools that enable best practice approach.
Lead CPE capability building by supporting onboarding. Ensure Harmonization of practice at study level, to ensure consistency, high quality, and efficiency.
May contribute to train FSP staff on CSL expectations.
Responsible for quality practices, management monitoring, control documents development, improvement support and training related to Study Delivery roles People Management
A Bachelor’s degree in Science or Pharmacy.
~12 or more years of relevant clinical research (or related) experience in the pharmaceutical industry.
~ Experience in study management, clinical-ops, human biological sample management and related process development.
~ CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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