Quality Assurance Manager

Career Category

Quality

Job Description

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

Manager QA

At Amgen Breda, medicines are labeled, assembled, stored, and eventually shipped to various countries worldwide. Every day more than 1000 people from 38 different nationalities are working on supply chain processes, manufacturing, marketing, and sales of our medicines and clinical research into new medicines.

LIVE

What you will do

Being in this role at the Quality team, you will be responsible for leading and directing Quality staff supporting production in the shift, including managing their performance and supporting their development.

The Manager QA is also responsible for providing guidance and direction to Production, Maintenance & Engineering, and Quality staff regarding compliance with quality standards and procedures. Optional, but not a requirement, you will be fulfilling the duties as a Qualified Person.

Let’s do this. Let’s change the world.

In this vital role, you will:

• Manage resource planning (e.g. shift roster, holidays) per business need
• Responsible for achieving Plant QA Key Performance Indicators
• Provide real-time QA oversight and support for production operations.
• Collaborate with operations to resolve quality and compliance issues. You will lead and assist in various investigations as needed.
• Review and approve cGMP records (e.g., Deviations, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
• Alerts senior management of quality, compliance, supply and safety risks
• Participate in internal audits and lead as appropriate, and in regulatory inspections and partner audits.
• Support Lean Transformation and Operational Excellence initiatives, drives continuous improvement initiatives within Plant QA, and drive together with production management reduction of repeating events within Plant QA and production.
• Provides training and advice to staff in order for them to perform their desired functions.
• Understand the interaction between batch review activities and batch disposition and align with PQA QP’s to enable batch disposition within agreed timelines.
• Optional: Execute batch disposition

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manager QA professional we seek is a team leader with these qualifications:

• Master in Science degree in Pharmacy or equivalent; OR any other Master’s degree education supplemented with relevant Pharmaceutical GMP experience.

• Previous practical experience in processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles, and validation; Typically 2+ years of related professional experience.

• Optional, but not mandatory: knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 68/01 chapter 2.2 (Responsible Person). The least requirement is to have thorough knowledge about these processes, but it is not a requirement to execute.

• Ability to problem solve and make scientific risk-based decisions;

• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with the ability to effectively communicate and collaborate with production and technical staff.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance, and collective health insurance.
• Focus on vitality with an on-site gym, vitality program, and a restaurant with healthy food.

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