Pharmaceutical Affairs Manager

Chiesi Group

Pharmaceutical Affairs Manager overseeing compliance and quality control in biopharmaceutical processes at Chiesi. Managing change control, SOPs, audits, and supplier qualifications in a collaborative environment.

Posted 5/6/2026full-timeVienna • 🇦🇹 AustriaJuniorMid-Level💰 €64,400 per yearWebsite

About the role

Key responsibilities & impact

Managing the Change Control process, including evaluation, coordination, and documentation of changes
Updating, maintaining, and harmonising SOPs, including the implementation of global procedures into the local Quality Management System (QMS)
Managing Technical Quality Agreements (TQAs), including regular reviews and revisions
Acting as back-up for the management of deviations and complaints, ensuring compliant and timely handling
Supporting audit activities, including audit planning, execution, reporting, and follow-up of corrective and preventive actions
Supporting supplier qualification activities, including documentation review and coordination with internal and external stakeholders
Organising and actively participating in cross-functional meetings related to the activities above

Requirements

What you’ll need

A university degree in pharmacy, chemistry, life sciences, pharmaceutical sciences, or a comparable scientific discipline with a relevant focus
Several years of hands-on experience in Pharmaceutical Affairs, Quality Assurance, or a comparable regulated environment
Proven practical experience with change control, SOP management, deviations, complaints, audits, and TQAs
Solid understanding of GxP requirements and quality systems in the pharmaceutical industry
Experience working with local and global quality processes and integrating global standards into local systems
Qualification as a Qualified Person (QP) is considered an advantage, but is not a prerequisite for this role
A collaborative, team-oriented mindset with the ability to work effectively in cross-functional environments
Strong communication and interpersonal skills, with confidence in interacting with internal and external stakeholders
A structured, reliable, and solution-oriented working style, combined with a high level of ownership
Fluent English, both written and spoken.

Benefits

Comp & perks

flexible working arrangements
remote work options
tax assistance services for foreign colleagues
competitive salary package
work-life balance initiatives
development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

change controlSOP managementdeviations managementcomplaints managementaudit planningaudit executionaudit reportingcorrective actionspreventive actionsTechnical Quality Agreements (TQAs)

Soft Skills

collaborative mindsetteam-orientedstrong communication skillsinterpersonal skillsstructured working stylereliable working stylesolution-orientedhigh level of ownership

Certifications

Qualified Person (QP)