GxP Quality Specialist job opportunity at Roche.

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DatePosted 2 Days Ago bot
Roche GxP Quality Specialist
Experience: General
Pattern: full-time
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loacation Copenhagen, Denmark
loacation Copenhagen....Denmark

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Roche Pharmaceuticals A/S is seeking a committed and agile GxP Quality Partner to serve as a Medical Compliance Lead and GCP/GVP Local Quality Responsible for our Affiliate business and medical teams. We are looking for an individual with a proven ability to drive a quality and compliance culture, manage compliance risks, and lead quality system initiatives, while also providing deep expertise in GCP/GVP and GMP/GDP operations and execution. We offer a challenging and varied job in an active and flexible working environment, where you will have independent responsibility for driving quality tasks and making an impact for our business. As a GxP Quality Partner, you will be part of a small team of dedicated Regulatory, Quality, Compliance and Business Partner employees, who work in a self-managed team with Regulatory, GxP quality assurance, Compliance and Business Enabling tasks often with short deadlines. You will also become part of an innovative and extremely dynamic organization. It is an independent job which is also characterized by teamwork and collaboration across the organization and across the Nordic Countries. Our Business focus is to bring Better outcomes for more patients faster . We motivate and encourage you to have a steep learning curve and for that, we offer you a good salary, pension, various insurances and many more employee benefits in a diverse and international atmosphere. We operate from our new offices in Carlsberg City which inspires innovative and cross functional cooperation across functions and teams. The Opportunity Lead the effective local implementation and maintenance of the Quality Management System (QMS), ensuring compliance with GxP requirements and the global Roche Corporate Quality System, and driving the process to measure and lead the overall Affiliate Medical Compliance Oversight including Management Reviews, monitoring activities, and escalation of key insights. Manage changes within the change control system, manage deviations and issues, and implement/maintain risk management for GxP-compliance risks. Drive CAPA management, training, procedural documentation and records management at affiliate level. Support audit and inspection readiness, preparation, execution, and CAPA response.  Deputizing for the Qualified Person (QP) and the Responsible Person (RP), hereunder performing import control, batch disposition, and release for distribution and sale of medicinal products for the Danish and Icelandic market. Implement and maintain robust global Service Provider and GxP Subcontractor Oversight, including the approval and auditing of all GxP-impacted activities, while defining and monitoring KPIs and metrics through dedicated quality checks to ensure continuous compliance. Partner with affiliate and global stakeholders as a trusted Local Quality Responsible, embedding a quality mindset across the business. Contribute to emerging quality areas such as RWE, Healthcare Solutions, and medical devices. Who You Are You hold a Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related scientific field and bring solid experience working in a highly regulated pharmaceutical environment. You have applied GxP expertise (ICH GCP, GVP, GMP, GDP) and the experience or readiness to act as deputy QP and/or RP, with the ability to be approved by the Danish Medicines Agency. You work in a structured, compliant and detail-oriented manner, ensuring high quality, documentation accuracy and adherence to procedures and timelines. You are a strong executor with business acumen, able to prioritize, deliver results and understand the impact of your work on broader business and patient outcomes. You communicate with clarity and credibility, challenge constructively and build effective relationships across a matrix organization. You are a collaborative team player who can also work independently, offering support to others and contributing to a culture of trust and high performance. You thrive in a fast-paced, changing environment, demonstrating agility, continuous learning, and a mindset of process optimization and improvement. You are fluent in Danish and English, both spoken and written.     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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