Specialist Quality Complaints
About this opportunity
Career Category
Quality
Job Description
At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.
Specialist Quality Complaints
Live
What you will do
We are seeking a Specialist Quality Complaints to join the Product Complaints and Surveillance team as a Complaint Owner. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connectivity across Amgen. The team is focused on maintaining complaint processes and systems in a compliant state through adherence to quality standards and procedures while meeting current and emerging internal and external requirements. In addition, the team leverages information from the market to drive continuous improvement initiatives.
As a Specialist Quality Complaints, you will facilitate cross-functional teams in conducting both basic and complex complaint investigations, determining appropriate corrective and preventive actions, and assessing their effectiveness. You will also ensure the appropriate level of control for products in distribution and align complaint closure activities with established process metrics to support timely and compliant record closure.
Let's do this. Let's change the world.
In this vital role you will:
Manage and investigate product quality complaints in compliance with applicable regulatory requirements and company procedures.
Conduct complaint assessments, trend analyses, and documentation activities to ensure timely and accurate resolution.
Facilitate cross-functional investigations and collaborate with Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and other key stakeholders to identify root causes and drive corrective and preventive actions (CAPAs).
Ensure accurate, complete, and compliant documentation within quality management systems.
Assess product impact and support decision-making related to product disposition and control in distribution.
Monitor complaint performance metrics and ensure adherence to established timelines and closure requirements.
Support Health Authority inspections and internal and external audits related to complaint management activities.
Communicate investigation progress and outcomes to relevant stakeholders while maintaining high standards of quality and compliance.
Analyze complaint data and trends to identify opportunities for continuous improvement and risk mitigation.
Support the implementation and ongoing enhancement of global quality programs, processes, and best practices.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a collaborative and detail-oriented professional with these qualifications:
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering or a related field.
Relevant experience in Quality, Quality Assurance, Quality Complaints, Manufacturing, Supply Chain or a regulated pharmaceutical/biotechnology environment.
Knowledge of GMP, GDP and quality system requirements.
Experience conducting investigations, root cause analysis and CAPA management.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills in English.
Ability to work effectively in a cross-functional and global environment.
Strong organizational skills with the ability to manage multiple priorities and deadlines.
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. Therefore, Amgen is regularly recognized as a Best Place To Work ©.
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 a collective health insurance.
Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 644 comparable Quality roles across 85 biopharma companies.
Salary context
110 of 644 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 644 comparable roles
+ 39 more countries
Seniority mix
309 of 644 peers have a known seniority level
Therapeutic area mix
0 of 644 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.