R&D Quality Manager

Posted 5 Days Ago
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Cambridge, Cambridgeshire, England, GBR
In-Office
Expert/Leader
Biotech • Pharmaceutical
The Role
The R&D Quality Manager at Sandoz oversees quality for medical devices, ensuring compliance with regulations and managing quality processes for product development.
Summary Generated by Built In

Job Description Summary

At Sandoz, our Purpose is pioneering access for patients

Job Description

The Quality Manages complex projects or late phase projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. 

Ensures that compliance with cGMP is maintained in Drug Delivery Device Development

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Quality responsible person for the assigned Design History File portfolio

  • Support quality aspects of development projects and/or processes assigned to department and assure compliance with Medical devices as well as Combination product regulations, good pharmaceutical practices and Sandoz internal standards.

  • Support quality problems and technical matters an ensure they are re-solved consistently and in accordance with global standards and policies.

  • Release of medical devices and device components of combination products for clinical batch production Represent Quality Drug Delivery Device Development in initiatives and cross-divisional projects

  • Perform or support inspections and audits as required Approval of Deviation and OOS/OOE and change Controls in Sandoz systems

  • Approval in document management systems

  • Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).

What you’ll bring to the role:

Essential Requirements:

  • Expert knowledge in Medical Device and Combination product regulations (EU MDR,  FDA CFR Part 820 and Part 4, ISO 13485)

  • Functional Breadth - Quality Management, Change Control and Audit Management

  • Project Management Skills - Critical Negotiations, Influencing Skills and Collaboration across boundaries

  • Excellent communication skills in English

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. 

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.  

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!  

  

Join us, help us make healthcare fairer and faster.  

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Change Control, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure)

Skills Required

  • Expert knowledge in Medical Device and Combination product regulations
  • Functional Breadth - Quality Management, Change Control and Audit Management
  • Project Management Skills - Critical Negotiations, Influencing Skills and Collaboration
  • Excellent communication skills in English

Sandoz Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.

  • Healthcare Strength Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
  • Retirement Support A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
  • Equity Value & Accessibility Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.

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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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