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Manager, Affiliate Quality Systems Standards and Governance

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Start date
Nov 16, 2023

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Job Description

Responsibilities:

  • You will report into the Sr. Director Affiliate Quality Operations
  • Managing the global affiliate quality management system compliance activities to ensure all policies, SOPs and work instructions remain up to date, are fit-for-purpose, harmonized and facilitate across the end-to-end global and local process workflow. Lead the update of procedures.
  • Work with the Affiliate Quality Leadership Team to identify Policy Owners, Business Process Owners and Local Process Champions and ensure Affiliate Quality Operations is represented at all Policy Governance Councils and communities of practice. Summarize main tasks and contribute to operational task planning.
  • Represent Affiliate Quality in Quality Management System Change Management meetings and escalate to Affiliate Quality Leadership Team proposed changes. Be the Change Coordinator for global or regional changes impacting the quality QMS within the affiliates and regions.
  • Help develop training criteria for Global Affiliate Quality teams across the affiliate network
  • Support Global Quality in inspection readiness by providing relevant data, updating existing presentations and statements, reviewing presentations, and being the Subject Matter Expert (SME) during internal audits and external audits by regulatory agencies or customers.
  • Consolidate and aligns with the AQOLT any Regions needs for technology (platforms, tools) and supports the creation of a formal business case, liaises with related Global Quality or ex-Global Quality functions as is appropriate.
  • Support deputy activities of regional affiliate quality lead and local quality officers when needed to include releasing product as deputy Local or Regional Quality Officer

Qualifications:

  • 5+ years' experience in a pharmaceutical or biopharmaceutical company
  • 5+ years' direct experience with QMS development and improvement at a local and/or global level.
  • 2+ years' experience executing Quality Assurance/Quality systems activities required
  • Experience in interacting with regulatory authorities including regulatory inspections a plus
  • Experience in project management highly preferred
  • In-depth knowledge of US, European, and/or Australian applicable regulations.
  • #LI-Hybrid

Fluency in English (written and spoken) required. Foreign language skills (especially Spanish and/or German) are beneficial. This role does not require travel.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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 organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Telephone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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