Director Quality Operations for Development Programs and Life Cycle Management

Confidential client

Graz, StyriaFull-timefrom € 75,000 gross/year

Leading quality operations for development programs with central responsibility for maintaining cGxP requirements throughout the product lifecycle. Ensuring GMP compliance during transfers from development to commercial manufacturing as well as during analytical and technical transfer processes.

Your responsibilities

Updating knowledge of cGxP regulations and applicable standards
Implementing regulatory requirements into local SOPs and work instructions
Managing the GMP-compliant transition of development programs into the commercial phase
Ensuring GMP compliance during tech transfers of active ingredients, finished products, and combination products
Creating, reviewing, and approving protocols, plans, and reports (e.g., validations)
Identifying risks in transfers and developing mitigation measures
Ensuring GMP compliance during analytical transfer activities
Managing change controls related to active ingredients, finished products, and combination products
Managing deviations, events, and CAPAs related to relevant products
Representing the Senior Director of Quality Operations in matters related to Quality Operations and Lifecycle Management

Your profile

Completion of BA/BS, MA/MS, or PhD in a technical or engineering discipline or related field
At least 10 years of experience in a quality function with increasing responsibility in biotech, life sciences, or pharma
Knowledge of ISO 9001 and ISO 13485
Knowledge of ICH Q8, ICH Q9, and ICH Q10
Understanding of cGMP requirements for pharmaceuticals and combination products including biologics
Understanding of GMPs and best quality practices for biotechnological manufacturing processes
Experience dealing with regulatory authorities such as FDA and EMA
Proven successes in third-party quality management
Excellent proficiency in English, both written and spoken
Demonstrated leadership qualities as well as high commitment, energy, and enthusiasm

Benefits

Location: Graz
Full-time
Start date: immediate
Permanent employment contract
Reliable employer
Strong global growth
International career opportunities
Comprehensive training and development
Active health promotion
Free parking

About the company

The advertising company is seeking reinforcement at the Graz, Styria location.

The client is treated confidentially in this process. You will learn the name during the application process.

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Your contact person

Julia Steiner

Talent Acquisition Specialist

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