Quality Assurance and Compliance SpecialistUnited States of AmericaR-0977692012 CSL Behring L.L.C.
With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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!
The Quality Assurance and Compliance is responsible for managing the end-to-end change control process as well as monitoring and ensuring compliance to GxP related activities within the assigned region. The position will also serve as a deputy LQO for the US Market as required.
What will you do:
Support and coordinate all Global Change Control (GCC) activities for the affiliates within the assigned region.
Establish and coordinate Affiliate Global Change Panel (GCP) meetings to standardize the change management process across the affiliate network.
Represent the Affiliates in changes initiated by other business functions including Site of Manufacture, Global Regulatory Affairs and Global Quality Systems. Participate and present changes during the Labeling GCP meetings.
Provide support to Affiliate staff on GCC setup and execution where appropriate by acting as the first point of contact and expert for change management questions and issues for the Affiliate Operations.
Monitor the Affiliates change control activity to help assure changes are implemented correctly, followed through, and closed on time.
Drive completion of GCC, Deviation and CAPAs across the assigned region. Escalate noncompliance appropriately.
Release product for the US market as well as performing release for Kankakee manufactured exports. Liaison with the appropriate manufacturing site representatives as necessary related to product for the US market. Serve as deputy for US LQO role.
Support the development and maintenance of Global Affiliate Quality Operations procedural documents.
Assure effective communication with internal/external stakeholders keeping stakeholders informed of progress, improvements and issues.
Serve as the KoP coordinator of Inspection Management for on-site KoP inspections. As requested, assist in providing necessary documentation for any global inspection in a timely manner by working with the necessary groups in order to acquire the requested documentation. Liaison with US Medical Information and US Customer Support as delegated for projects or product concerns related to customer inquiries.
Requirements for the role:
Minimum 3 years of experience working within relevant pharmaceutical industry GxP role/s. Excellent personal, communication and collaboration skills
Computer literacy required. Foreign language skills (especially Spanish and/or German) are beneficial. This role requires limited travel.
Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
At least 3 years' experience working in a cGMP regulated environment
State/Province : Pennsylvania
City : King of Prussia
Street Address : 1020 First Avenue
Primary Location : CSL Behring King of Prussia
Full Time/Part Time : Full Time
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement