Amgen Responsible Person - Quality Sr. Manager in Breda, Netherlands
Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.
At Amgen Breda, The Netherlands, we focus on the packaging and distribution part of the drugs we have developed which are produced at our international sites. The packaging and distribution is supported by the Operations, Customer Service and Demand, Information Systems and Quality departments.
The site also supports a sales organization.
Process Development, Operations and Quality (POQ) are the core divisions of Amgen that make sure the drugs are delivered to our patients. Made up of seven functions and spread across seven sites, POQ's aspiration is simple: Supply every patient, every time!
Currently we are looking for a Responsible Person - Quality Sr. Manager
As Responsible Person - Quality Sr. Manager you understand the role of Medicines and Healthcare products Agency in the licensing of medicines and as the competent authority including the risk-based inspection process, the role of the enforcement group, the Inspection Action Group and resulting actions that can be taken due to non-compliance. You know all there is to know about the Dutch regulations in relation to Wholesale Distribution. And you fully understand the European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products. Your knowledge on Good Distribution Practice (GDP) is excellent and you understand the importance of a clear reporting line to the wholesale distribution authorisation holder, senior manager and/or CEO.
In addition, the Responsible Person - Quality Sr. Manager also has knowledge of:
the role of the professional bodies and organisations that regulate those supplying medicinal products to the public.
the role of the European Medicines Agency (EMA) and use of EUDRAGMDP.
the Falsified Medicines Directive.
the Principles and Guidelines of Good Manufacturing Practice and how the principles of GDP. maintain product quality throughout the distribution chain.
The Responsible Person - Quality Sr. Manager should have:
the prior relevant knowledge and experience related to the distribution of medicinal products.
access to pharmaceutical knowledge and advice when it is required knowledge of the products traded under the licence.
As the Responsible Person you ensure that a quality management system proportionate to the distributor's activities is implemented and maintained including:
Quality Risk Management.
Corrective and Preventative Actions (CAPA) to address deviations.
Measurement of performance indicators and management review.
Medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP.
Products are delivered to the right recipients within a satisfactory time period.
Deviations from established procedures are documented and investigated.
Appropriate corrective and preventive actions are taken to correct non-conformances and prevent them in line with the principles of quality risk management.
Assessing new regulations, guidance and quality issues that can impact the quality management system.
ensure that appropriate standards of GDP are maintained for own premises and contracted storage premises.
identify medicinal products, legal categories, storage conditions and different Marketing Authorisation types.
demonstrate oversight of direct and indirect contractors.
A University or Bachelor + Masters Pharmacy qualification or related education.
At least 5-10 years of related Quality Assurance experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in investigations, change control, validation and/or audits
At least 3-5 years of supervisory experience.
Expert knowledge of Quality Assurance principles, in both routine and non-routine cases.
Extensive knowledge of the Global Regulatory principles and guidelines of Good Manufacturing Practice and how the principles of Good Distribution Practice maintain product quality throughout the distribution chain.
Fluent in Dutch and English, in both oral and written communication.
Experience in working in an international environment.
Structured approach with appropriate level of detail.
Excellent knowledge of warehouse and manufacturing processes and operations.
Excellent knowledge of GxP change control, investigations, validation and training requirements, with proven ability to apply to business improvement.
Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
That's why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.
Please note that an online assessment is part of our recruitment process.