CSL Behring
- Lead Quality Engineer Combination Products
At a glance
Location: US-PA-King of Prussia Map
Posted: 05/08/2021
Closing: 06/07/2021
Degree: 4 Year Degree
Type: Full-Time
Experience: At least 5 year(s)
Job description
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven 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 and Seqirus. 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. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Responsibilities: • Responsible for maintaining Quality Assurance Systems/affiliate quality management system to ensure compliance with company standards and regulatory guidelines • Manages staff and GMP systems for ensuring quality of incoming materials /timely release of CSL products to the market • Supports investigations/affiliate recalls and reporting of product technical complaints and ensures remedial actions are implemented • Collaborates cross-functionally to resolve customer inquiries and possible temperature storage concerns • Establishes and maintains GXP training and site quality policies, SOPs and work instructions • In conjunction with Global Supplier Quality, supports maintenance and management of Quality Agreements Qualifications: • Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) • 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry • Demonstrated leadership/management skills • Experience within a global matrix organization • Knowledge of current Good Manufacturing Practices (cGMP) principles • Knowledge of appropriate regulatory requirements Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Lead Quality Engineer Combination Products