Pharmaceutical Affairs Manager (Pharma)

TL;DR

Pharmaceutical Affairs Manager (Pharma): Managing the Change Control process and quality management systems for a biopharmaceutical group with an accent on SOP harmonization and technical quality agreements. Focus on ensuring GxP compliance, coordinating audits, and implementing global quality standards into local systems.

Location: Vienna, Austria. Remote work options and flexible working arrangements available.

Salary: base salary starting from 64,400 EUR

Company

hirify.global is an international research-focused biopharmaceutical group with 90 years of experience, operating in more than 30 countries.

What you will do

• Manage the Change Control process, including evaluation, coordination, and documentation of changes.
• Update and harmonize SOPs, implementing global procedures into the local Quality Management System (QMS).
• Manage Technical Quality Agreements (TQAs), including regular reviews and revisions.
• Act as back-up for the management of deviations and complaints to ensure compliant handling.
• Support audit activities, including planning, execution, reporting, and follow-up of CAPAs.
• Coordinate supplier qualification activities and documentation review with stakeholders.

Requirements

• University degree in pharmacy, chemistry, life sciences, pharmaceutical sciences, or a comparable scientific discipline.
• 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 integrating global quality standards into local systems.
• Fluent English, both written and spoken.

Nice to have

• Qualification as a Qualified Person (QP).

Culture & Benefits

• Competitive salary package starting from 64,400 EUR.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.
• Top-class benefits and work-life balance initiatives.
• Professional development opportunities with access to resources and training.