Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

** 24 month contract 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  Lead Investigator you will execute complaint investigations and the complaint trending process for Roche commercial products, with a focus on the Port Delivery Platform (PD-P), a Class III medical device used in combination with Roche pharmaceuticals. Your scope of accountability includes clinical and commercial complaint investigations. You will be responsible for conducting root cause investigations, perform trending along with reviewing and approving records in the Quality Management System.  You will drive the resolution of issues identified during the investigations and those related to the complaints process.

The Opportunity:

You will lead product complaint investigations (critical and non-critical) with minimal guidance and drive investigation action plans that ensure robust root cause analysis.  You will craft investigation summaries that are accurate, include appropriate corrective actions, and follow company standards and vigilance reporting requirements. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies. In addition you will present at the Quality Review Board(QRB).

  You will triage, initiate, coordinate, investigate and track complaints as Lead Investigator or act as complaint QA and close/approve complaints and 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 product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations, Legal Manufacturer requirements, and Genentech standards.

You will assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes and present product complaint records and/or reports during periodic audits and regulatory inspections.

You will review completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements.

 You will gather data to assist with any potential recall and/or reporting actions and create risk metrics on failure modes and complaint-related CAPA trend analysis records; and submit data to management to ensure early detection of potential quality issues.

Support continuous improvement activities and projects (e.g. Quality systems support, batch record review) in accordance with applicable regulations and business goals and objectives as well as write, review, and approve CAPAs to ensure timely resolution of quality problems.

Who you are 

You will have a B.A., B.S., or Higher degree (preferably in Life Sciences) with 8 years of relevant experience in the pharmaceutical, biopharmaceutical, or medical device industry along with experience in quality and pharmaceutical or biopharmaceutical manufacturing and technical writing.

You will have strong knowledge of GMP, Quality Systems, Global pharmaceutical/biotechnology industry regulations, Health Authority regulations, and Roche standards and guidance documents. This includes the ability to apply this knowledge to interpret and relate quality standards for implementation and review.

You will bring  experience in Quality and pharmaceutical or biopharmaceutical manufacturing along with strong knowledge of analytical data, critical thinking skills, proficiency in the application of statistics and proficiency across technology platforms.

You will demonstrate capability of managing Product Complaints, Sample Retrieval, Root Cause Investigations, CAPAs, Vigilance Reporting and Reconciliation as well as experience with enterprise databases, collaboration platforms, and analytics (IT platforms).

You will bring experience with using quality-related tools, including Six Sigma / DMAIC, for problem solving and decision making.

You will bring the ability to work in cross-functional teams to resolve technical, quality, and business-process related issues; extract optimized business results through skillful collaboration and application of principles for influencing without formal authority.

Preferred:

Your technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as their associated control systems as well as  knowledge of Medical Devices and Device Combination Products is a plus.

**Relocation benefits not eligible for this position**

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.