Operations Quality - Senior Quality Partner (m/w/d)

Roche; Mannheim; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading global health company in Mannheim is seeking a Senior Quality Partner to ensure compliance and quality in processes. The ideal candidate has a Master's degree and at least 5 years of experience in quality assurance within the pharmaceutical industry. This role includes conducting reviews, training team members, and ensuring adherence to quality standards. Fluency in German and English is required.

Qualifikationen

• 5+ years of quality assurance experience in chemical-pharmaceutical.
• Specialist knowledge of quality assurance guidelines for medical devices.
• Fluent in German and English for communication.

Aufgaben

• Conduct independent reviews and approvals of IRM cases.
• Ensure processes are completed before production release.
• Plan and conduct training sessions on guidelines and tools.

Kenntnisse

Quality assurance expertise

Communication skills

IT skills

Training and coaching

Document writing

Ausbildung

Master's degree in natural sciences or Ph.D.

Tools

MS Office

SAP P1U

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.

Who We Are

We are the Quality & Regulatory department of the Roche Diagnostics Division, ensuring our products are available to healthcare systems in the highest quality and sufficient quantity. We contribute to the prevention and diagnosis of diseases, benefiting millions of patients worldwide.

Global Operations Quality

The Global Operations Quality unit is part of the Global Quality & Regulatory function and a key partner for internal and external stakeholders. We ensure compliance with global quality and regulatory requirements. Our team is diverse and addresses serious topics while maintaining a fun work environment.

Your Position

As a Senior Quality Partner, you will promote business results and customer benefits. This includes independently performing activities required to achieve Q&R goals. Your passion is training and coaching other business partners, navigating complex situations, writing and reviewing documents, and developing independent solutions.

• Conducting independent reviews and approvals of IRM cases (e.g., OOS, NC, CAPA, variance) according to the valid mQMS guidelines.
• Ensuring that batch-related processes are completed or approved before release (Batch Record Review & Product Release).
• Supporting batch record review and product release processes, as well as change management with Sub-Network colleagues.
• Communicating effectively with production and quality control interfaces.
• Developing and implementing quality processes and tools.
• Planning, preparing, and conducting training sessions on processes, guidelines, and tools (e.g., GMP, ZM-Tool).
• Assisting with inspection and audit preparation and execution.
• Collaborating in global working groups.

Your Profile

A Master's degree in natural sciences (e.g., chemistry, biochemistry, biology, biotechnology), preferably with a pharmacy approval or Ph.D.
• At least 5 years of experience in quality assurance in the chemical-pharmaceutical industry, with specialist knowledge of quality assurance guidelines for medical devices/IVDs (FDA, DIN/ISO standards 9001 and 13485, QSReg).
• Good IT skills (e.g., cSuite, MS Office/Word, Excel, PowerPoint, SAP P1U).
• Fluent German and English language skills for local and global communication.
• Careful, organized, reliable, and responsible work approach.
• Engaged, team-oriented, and motivated personality.
• Persuasive presentation and good communication skills.

Please note: Due to close collaboration with internal and external operational units, we expect the future job holder to have regular attendance in Mannheim for Gemba walks and other shop floor QA activities.

Application Documents:

Please submit your current resume and official educational certificates/documents. Additional documents are not required at this time.

Roche is an Equal Opportunity Employer.