Manager, ESQA, Global Strategic Projects

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jul 10, 2021
Ref
R-135075
Required Education
Bachelors Degree
Position Type
Full time

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:
• Under general direction, supports a compliant end-to-end business process for all raw materials and respective suppliers
• Serves as primary local site interface and point of contact for all quality related supplier and raw material issues
• Collaborates with colleagues to manage overall supplier quality auditing program; performs quality audits of approved or potential suppliers
• Identifies and uses best practices to establish appropriate risk management tools and quality KPIs for local operations/quality groups
• Serves as primary Quality point of contact for deviation review meetings and assists with deviation investigation processes
• Supports activities of supplier quality agreements including writing, editing, reviewing, updating and routing agreements for approval

Qualifications:
• Bachelor degree in relevant business or science discipline
• 5+ years' experience in a GxP environment
• Manufacturing experience in pharmaceutical, medical devices or related industry
• Experience within a global matrix organization, preferably in the pharmaceutical/biotech industry or other regulated industry
• Knowledge of required regulations including FDA, PiC/S and European regulation, Therapeutic Goods Authority, Canadian Health Authority, etc.
• Auditing knowledge and experience

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.