Job Description

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

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That's what makes us Roche.

As a Principal Technical Manager and Lead Investigator, Device Complaints you will be a Technical Subject Matter Expert (SME) accountable for developing and maintaining innovative, harmonized, compliant and sustainable quality systems and business management processes for Global Device Quality - Device Complaints (e.g., device complaints and global operational process governance). Notably, this role ensures global process compliance to GMP regulation and ensures compliant delivery of complaint investigations, leveraging matrix leadership and peer-coaching. This role also drives automation continuous process improvement (e.g., process automation and CAPA).


You will also execute the complaint investigations and trending process for Roche products, including Devices, Combinations Products, and Drug Delivery Systems, with a focus on the Port Delivery System (PDS). The scope of accountability includes complaint investigations where material was used in clinical trials or supplied to the commercial market. The overall aim of this work is to respond to issues in the market (or clinic) and to identify trends and issues that affect the overall state of control of products and their manufacturing process, and, if necessary, identify appropriate actions for product quality issues.

The Opportunity:

You will lead all product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. You will collaborate and influence cross-functional departments (e.g., Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies. You will lead and facilitate root cause analysis and effectively present findings and recommended actions at QRB. You will manage Global Complaints for Devices, Combination Products, and Drug Delivery Systems that were manufactured, packed, labeled, or shipped by Clinical and Commercial Supply or on behalf of Global Clinical Supply and Global Supply Chain. You will initiate, coordinate, and track complaints as Lead Investigator or act as complaint QA and close/approve complaints. You will apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems. You will develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations, Legal Manufacturer requirements, and Roche standards.

Who you are:

You will have a Bachelor's degree (preferably in Life Sciences) with a minimum of 12-15 years of relevant experience, a Master's Degree with 10-13 years, or a Ph.D with 7-10 years in the pharmaceutical, biopharmaceutical, or medical device industry. You will possess experience with technical writing. You will demonstrate technical expertise in small and large molecule drug substance and drug product manufacturing processes and their associated control systems, with advanced knowledge of Medical Devices, Combination Products, and Drug Delivery Systems. You will have experience using quality-related tools, including Six Sigma / DMAIC, for problem-solving and decision-making. You will demonstrate strong knowledge of GMP, Quality Systems, Global pharmaceutical/biotechnology industry regulations, Health Authority regulations, and Roche standards and guidance documents. You will demonstrate capability in managing Product Complaints, Sample Retrieval, Investigations, CAPAs, and Reconciliation. You will demonstrate excellence in communication, including effective facilitation skills, and will be fluent in English.

TRAVEL REQUIREMENTS

Ability to travel according to the needs of the business (estimated 5% or less).

Relocation benefits not available for this position


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.