The LA 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

o   CMOs,

o   API manufacturers,

o   Contract laboratories,

o   Packaging material suppliers,

o   Medical device supplier,

o   Logistic/distribution partners,

o   IT service/software providers

o   Pharmacovigilance service providers

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

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, as requested

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 (as Required):

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, if requested

Consolidate gap assessments of findings across Xellia Pharmaceuticals sites to ensure that gaps are addressed globally, if requested

Support the review of industry/regulatory trends and perform the impact assessment to the relevant Xellia Pharmaceuticals processes, if requested

Attend global quality projects on behalf of CAC and give support from an audit perspective

Requirements:

Background: Chemistry, Bio-chemistry, Pharmacy (university degree)

Min 7-10 years of experience in auditing of critical GMP Compliance systems, CMOs, different type of vendors/ materials, GxP service providers, Pharmacovigilance service providers, IT service providers

Aseptic manufacturing experience / regulations/ auditing knowledge ( API/ FDF)

API manufacturing / regulations knowledge

Quality control experience

Good communication skills

Experience with Health Authority inspections (EU, USA, RoW)

Experience with multicultural business relationship

Driver license “B” category

Fluent in English (verbal / writing)

Flexible to travel 50%

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
Good team spirit and friendly colleagues
Stable international company background
Multinational working environment
Home Office or full remote opportunity 

If you are interested please visit us at booth 16.