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Manager Product Quality Compliance

AOP Orphan Pharmaceuticals GmbH -
Wien, W

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Details zur Stelle

Vollzeit

Qualifikationen

Bachelor

Vollständige Stellenbeschreibung

Full-time Vienna

We are looking for an experienced Change Control Manager to ensure compliant management of product-related quality activities across the product lifecycle. In this role, you will oversee the Change Control process, ensuring changes to products, processes, systems, and documentation are properly assessed, approved, implemented, and documented in line with quality and regulatory requirements. You will also support the preparation, review, and follow-up of annual Product Quality Reviews (PQRs).

What Your Day To Day Will Look Like

Product Change Control Management

Manage the end-to-end Change Control process within the established Quality Management System (QMS)

Drive the development, harmonization, and implementation of standardized Change Control processes, workflows, and best practices to enhance efficiency, compliance, and consistency

Review, assess, and coordinate proposed changes to ensure adequate impact assessments are completed

Monitor change implementation activities and ensure the timely completion of required actions.

Collaborate with Technical Development, Regulatory Affairs, Supply Chain, and other stakeholders.

Act as Change Owner, Stakeholder and supporting Quality function throughout the whole change control lifecycle

Product Quality Review (PQR)

Contribute to the preparation, review, and maintenance of annual Product Quality Review (PQR), including PQRs provided by Contract Manufacturing Organizations (CMOs)

Monitor and drive the timely completion of CAPAs and quality improvement actions arising from Product Quality Reviews (PQRs)

Quality Systems & Documentation

Prepare, review, and maintain SOPs and quality-related documentation e.g. Key documents

Act as Subject Matter Expert (SME) for the operational end-to-end management of Change Controls and Product Quality Review, supporting internal audits, customer audits, and regulatory inspections through the preparation and presentation of corresponding documentation

Collaboration & Quality Support

Provide quality oversight and guidance to cross-functional teams (e.g. Regulatory, Technical Development)

Proactively identify quality risks and drive mitigation strategies

Collaborate closely with CMOs on product quality topics

Performance & KPI Management

Support quality KPI definition, monitoring, trending, and reporting

Contribute to continuous improvement initiatives based on operational quality metrics

Your Qualifications And Experience

Bachelor's degree / or adequate (e.g. higher technical school in natural science) in a relevant scientific discipline

professional certification in Quality Management / GMP is an advantage

Min. 3 years of experience in a similar role within the manufacturing/quality department/QC of pharmaceutical industry

Strong hands-on experience with change control management and Product Quality Report

Solid understanding of GMP and regulatory expectations (EU, FDA, ICH guidelines)

Structured, solution-oriented mindset with high attention to detail

Experience working with CMOs, including the ability to challenge quality topics constructively in a professional manner

Confident communicator, able to explain quality requirements clearly to internal/external partners

Fluent in German and English (written and spoken)

professional technical writing skills

Our offer

Open corporate culture with the opportunity to bring in your own ideas
Great opportunities for personal and professional development
Attractive work environment with excellent career opportunities and flat hierarchies
Competitive salary package plus bonus and various benefits
Gross annual salary provided for this function is a minimum of EUR 45.080,- based on full-time employment (38,5h/week). Any potential overpayment depends on professional experience and qualifications.

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Please submit your application exclusively via the application link.

Main Benefits

Bonus

Homeoffice

Employee mobile phone

Flexible working hours

Laptop

Initial and continuing education

Canteen

Good transport connection

Employee events

Meal allowance

Company doctor

Parking spot

Healthmeasures

Employee discount

Your Contact

Kenny Trappl

Talent Acquisition Manager

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