Quality & Process Partner

Roche; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Roche is seeking a Quality & Process Partner in the pRED Clinical Operations group to guide quality and process optimization across studies, audits, and inspections. You will drive CAPA, risk assessment, and continuous improvement, collaborating with global teams to ensure GCP/GVP compliance.

You bring deep experience in pharmaceutical quality, process management, and regulatory requirements, with a university life sciences background. International travel may be required.

Qualifikationen

• University degree or equivalent years of experience, preferred focus in life sciences.
• Extensive experience in pharmaceutical/healthcare industry and drug development.
• Strong knowledge of GCP/ICH and worldwide regulatory requirements.
• Proven ability to lead quality and process improvements and CAPA activities.
• Experience with risk management tools within the clinical quality framework.

Aufgaben

• Provide strategic oversight on quality issues arising from pRED studies and ensure action plans are implemented.
• Act as content expert for Quality & Processes across pRED Clinical Operations and DTAs.
• Support HA inspections and internal audits, including CAPA activities.
• Develop and execute continuous improvements related to processes and findings.
• Maintain metrics for quality and productivity; align QMS with global standards.
• Collaborate across Roche chapters and enterprise to ensure fit-for-purpose processes.

Kenntnisse

Quality management

Process improvement

GCP/ICH knowledge

Regulatory compliance

Project management

Ausbildung

University degree in life sciences

Tools

Six Sigma

LEAN

Value stream mapping

Modeling & simulation

Jobbeschreibung

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

As a Quality & Process Partner in our Research and Early Development (pRED) Clinical Operations department, you will support Clinical Operations (CO) strategic directives by ensuring the proactive development and management of optimal business processes that enable compliance and highest quality standards are met. The postholder will collaborate with stakeholders within Research and Early Development (pRED) and across the enterprise, as well as represent CO in the respective areas of Process Management as well as Quality and Compliance as it relates to GCP/GVP.

In pRED CLINICAL OPERATIONS our North Star is to increase R&D Productivity and Patient Centricity. This is supported by our CO Strategy to deliver value for pRED CO, pRED BHAGs and our portfolio. We aspire to be a leading edge Clinical Operations organisation that drives innovative patient-centric approaches in study design and execution, utilizes advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to improve productivity delivery of programs and studies. We strive to create a workplace where team members own their own development and learning and are empowered to create and innovate.

The Opportunity:

• Providing strategic oversight and direction on how best to address all quality issues arising from pRED studies (via audits or otherwise) and ensures action plans are created and implemented to address findings. Ensures learning from audits are consistently shared within all applicable areas of pRED Clinical Operations and DTAs
• Functioning as the content expert for Quality & Processes across all relevant pRED Clinical Operations and DTAs groups, this includes the proactive identification of risks and proposal for risk mitigation strategies. Providing the required support during HA inspections and internal audits, including leading CAPA related activities
• Developing and executing continuous improvements as they relate to processes and audit/inspection findings
• Developing and maintaining metrics in the relevant areas (eg quality and productivity measures)
• Ensuring pRED Quality Management System (QMS) activities are aligned with global GCP/GVP QMS
• Staying abreast of internal and external developments, trends, and other dynamics relevant to the work of Clinical Operations
• Collaborating with colleagues across chapters and the Roche Enterprise to ensure fit for purpose processes

Who You Are:

• You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit
• Have a growth mindset and are excited about learning through experience
• Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments
• Have extensive years of experience in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus)
• Demonstrates the ability proactively, Quality and Process solutions with the ability to manage emergent compliance risks
• Hold a university degree or equivalent years of experience, preferred focus in life sciences
• Find passion in achieving successful outcomes by leading, coaching and inspiring others
• Want to make a difference and find excitement in innovating practices, therapeutics and processes
• Possess strong working knowledge of drug development process and respective regulations
• Feel comfortable traveling internationally based on specific program needs
• Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
• Strong project management and process improvement skills. Sound knowledge working with operational excellence methodologies and tools, such as value stream mapping, business process redesign, Six Sigma, LEAN, modeling and simulation, cycle time reduction, etc
• Experience with risk management tools and processes within the clinical quality framework
• Able to act urgently for health authority inspection matters and are experienced with delivering effective CAPA management solutions
• Ability to analyze, interpret and solve complex problems
• Ability to think objectively and with creativity and innovation

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.