Clinical Quality Assurance Lead

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jan 13, 2021
Ref
R-127431
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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 developing, maintaining and improving Clinical Quality Assurance CQA programs for pre-clinical and/or clinical development
• Ensures resources for audits, including hands on participation, to assess quality of scientific data and ensure compliance with regulatory requirements
• Provides expert guidance on applicable GXPs and compliance related issues and questions
• Develops metrics, identifies trends, and evaluates effectiveness of completed Corrective and Preventative Actions (CAPAs) to drive continuous improvement
• Develops and maintains procedural documents (SOPs) and tools to ensure regulatory compliance and consistency across Global R&D Quality/Global CQA
• Manages inspection readiness by leading pre-inspections, mock-inspections and related follow-up activities to support hosting and/or facilitating regulatory agency inspections

Qualifications:
• University degree (BSc/MSc) in scientific discipline/life sciences or related discipline
• 7+ years' experience in CQA compliance in a pharmaceutical company or clinical research organization
• Knowledge of Good Clinical and Good Laboratory and Quality Management System/audit procedures, reporting and CAPA management
• Thorough knowledge of drug development process and international and national regulations

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