Manager, Quality Assurance

The Amgen International & Distribution Quality team is looking for an experienced Quality Manager with relevant quality/ supply chain/ compliance experience to support a diverse portfolio of regional activities across Europe. If you are looking for your next career step within the Quality field and want to be part of our mission – to serve patients – which drives all that we do, apply, or get in touch.

Role overview:

As Manager Quality, you will be responsible for supporting projects and programs applicable to International & Distribution Quality (IDQ) operations in support of oversight of supply of pharmaceutical products and ensuring the compliance of Good Distribution Practices (GDP) within the EMEA region for the storage, transportation, and delivery of medicinal products. Oversee the quality management system (QMS), support audits/self-inspections and Health Authority inspections, manage, review, and approve quality records, such as Deviation, CAPA, CAPA EV, Change Control, Continuous Improvement initiatives.

You can act as RP/RP back up, maintaining full compliance to procedures and appropriate regulations report to senior management.

Leverage knowledge and expertise to provide training and guidance to staff and IDQ stakeholders. You will be accountable for Quality activities and oversight of strategic projects for IDQ.

Responsibilities:

Support processes and activities to ensure GDP compliance including but not limited to the following:

• Support the Deviations process by acting as owner or quality contact of records within Supply chain and Quality

• Support the corrective and preventive process, where required, to correct deviations and prevent re-occurrence in line with Amgen’s Quality processes

• Support tracking of completion of Quality owned records

• Participate in different regional initiatives by providing awareness sessions to Quality and Supply Chain staff owning Deviation/CAPA/EV records to support procedural compliance

• Responsible for working collaboratively and cross-functionally with internal and external stakeholders and providing Quality oversight for distribution and transportation activities to ensure pharmaceutical products are distributed according to current Good Distribution Practices (cGDP) and other applicable pharmaceutical regulations to maintain product quality, efficacy and safetyProvide Quality oversight to ensure that products are distributed according to current Good Distribution Practices (GDP) and escalate issues when required

• Act as quality reviewer and/or approver for controlled documents owned by supply chain  

• Support to assess planned changes (including but not limited to changes related to Product launches and commit to retire records) and in partnership with country Responsible Persons (RPs) ensure any changes that could potentially impact drug licenses/drug approvals are managed accordingly to ensure continued compliance with regional and local pharmaceutical legislations.

• Quality oversight and ownership of continuous Improvement initiatives, programs, and projects, within Quality or Supply Chain organizations.

• Alerts senior management of significant quality, compliance, supply and safety risks and participates in recalls as necessary.

Qualifications and required experience:

• In-depth understanding of the: European Pharmaceutical Directive related to Distribution of Medicinal Products Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP) and the Falsified Medicines Directive and Role of the European Medicines Agency (EMA) and Country Health Authorities in EU

• Fluency in English language.

• Life Sciences degree or degree in an associated disciplinary field

• Relevant quality and/or supply chain experience

• Strong organizational skills

• Ability to multitask and prioritize

• High attention to detail and accuracy

• Proficient in quality management systems, ERP system and Microsoft Office