CSL Behring Hiring for Safety Systems Program Lead job in King of Prussia Full Time

The Opportunity
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. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Are you the next Safety Systems Program Lead for CSL. You can work at any CSL office worldwide. It is a hybrid role. You will report to the Head Business Process and Technology.

You will have direction and oversight for all projects within Pharmacovigilance. These projects may be technology, system, or process improvements.

The purpose of this position is to advise, direct, plan and manage new projects intended to modernize or enhancement processes across GCSP. You will work with the GCSP LT to advise and direct on transforming strategic goals into technology or system Projects through business case supporting all the necessary benefits and risks improving us.

You will provide expertise in driving process improvements that allow efficient and compliant Pharmacovigilance operations and delivery. You will apply leading process improvement methods (e.g., Lean, Six Sigma) to define main process issues, measure current state, assess strategic options for improvement, and identify improvement opportunities and projects. Support project team in establishing a baseline for identified problem statements and setting up appropriate metrics to track consistency and efficiency of revised processes.

You will also have a both a strategic knowledge for the roles and responsibilities of the entire project team – being able to direct the team to focus on the strategic milestones and the important technical aspects to ensure understanding of requirements.

RESPONSIBILITIES

You will ill Provide Strategic direction into the GCSP long range technical roadmap considering the current system landscape and strategic goals for Pharmacovigilance including research on new trends and technologies to further improve internal capabilities.

You will conduct Project management analysis including business case development, decision support, and shepherding project through concept and approval phases including defining funding needs

Project management for all phases of technical projects within Pharmacovigilance including concept through deployment, hypercare, and lessons learned (closeout) phases including securing internal/external budget and resources, tracking risks, communicating with leadership team, and providing regular status updates

EXPERIENCE

Bachelor of Science in Engineering, IS/Computer Science, or Data Analytics Degree (BSc/MSc/Diploma), Quality or Operations Management, Management Information Systems, or Business Analytics or equivalent.

10+ years experience in pharmaceutical industry preferable R&D area, 7+ years of Pharmacovigilance experiences

Advanced knowledge into the medical, safety or regulatory function is an advantage.

Practical experience IT Software Life Cycle processes and computer validation including Quality Management Systems (QMS) procedures.

Experience in process design including Standard Operating Procedure (SOP) writing and training documents such as working instructions, job aids, or tip sheets.

BENEFITS

Medical, Dental Vision

401K

Paid time Off

#LI-Hybrid

Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. 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.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!