The CLA partners with site stakeholders/site quality leaders to ensure inspection readiness and high compliance level of all Xellia Pharmaceuticals sites, critical vendors and CMO/service providers. This is ensured by continuous monitoring through internal/external audits of the mentioned parties.

Responsibilities

External/Internal Audits: 

Set-up and maintain policies/procedures defining external/internal audits process/responsibilities
Contribute to preparation of the annual internal/external audit plans
Assessment of new audit requests (ACRF)
Perform internal audits at Xellia Pharmaceuticals sites per annual internal audit plan
Support the sites for internal audit CAPA plan definition/implementation
Conduct external audits at CMOs, API manufacturers, CLOs, material suppliers, medical device supplier, clinical study providers, logistic partners, pharmacovigilance service providers and other partners/service providers as per company procedure 
Plan, execute/participate, write the audit report and follow-up on action plans for internal/external audits
Escalate compliance issues with potential impact/risk for Xellia Pharmaceuticals business/company reputation and provide insights on how to address the gap relevant for Xellia Pharmaceuticals stakeholders/management as per company procedure  
Advise/ support consultants while performing external audits on behalf of the Xellia Pharmaceuticals (preparation, audit execution, CAPA plan agreement/implementation, etc.)    
Contribute to preparation of trend reports
 

Part Time Lead Auditor (PTLA) Program:

Participate in the PTLA program
Mentoring of PTLAs and monitor PTLAs performance

Customer Audits and Regulatory Inspections: 

Ensure Xellia Pharmaceuticals inspection readiness through execution of the internal audit plan
Assist the sites during customer audits/regulatory inspections and support in providing responses, if requested
Act as a subject matter expert during customer audits/regulatory inspections
 

Supplier Surveillance:

Provide input/support from the audit perspective in establishing quality requirements, prepare and approve policies/procedures
Review contracts, if deemed relevant
 

Other Responsibilities: 

Provide training as subject matter expert to internal stakeholders, if deemed relevant
Provide guidance and share solutions to Xellia Pharmaceuticals sites and external suppliers for compliance issues
Consolidate gap assessments of findings across Xellia Pharmaceuticals sites to ensure that gaps are addressed globally
Support the review of industry/regulatory trends and perform the impact assessment to the relevant Xellia Pharmaceuticals processes
Attend global quality projects on behalf of CAC and give support from an audit perspective
 

What we offer

Competitive compensation and benefit package
„Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
Opportunity to learn and develop
Stable international company background
Multinational working environment
Home office or full remote contract opportunity

If you are interested please visit us at booth 16.