We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
Our mission in External Quality Validation is to sustain and enhance Quality and Compliance for Roche products manufactured in external manufacturing network in collaboration with our internal and external partners.
We achieve results through innovation, lean thinking, and execution, and smart risk taking. We prioritize value-added work that has positive impact on the business and our ability to deliver high-quality product. We continuously learn, develop, share knowledge, and work as a team with a common vision and purpose. We build-up a professional, trusting, and collaborative work environment so that our people feel valued and respected.
Main purpose of the role as a Senior/Principal Technical Manager is to provide Quality oversight of Validation & Qualification activities at Contract Manufacturing Organizations (CMOs) in compliance with cGMP and applicable regulations in order to ensure the quality of Roche products. In this position you will be the Subject Matter Expert (SME) in Validation & Compliance ensuring Health Authority expectations are met, and industry standards and/or best practices are incorporated to enable effective and compliant execution of Technology Transfers and Product Launches.
For assigned projects you will be the Project Quality Lead (Commercial) for the design and execution of Quality & Validation strategies. In addition you will provide ad-hoc support to CMO’s Make-Assess-Release operations, as requested by External Quality, External Manufacturing and/or Joint Management Teams.
Your main responsibilities will be to:
Assess Qualification & Validation methodologies at CMOs against health authority regulations, industry standards and Roche internal requirements
Author/Review assigned sections of CMC dossiers for regulatory submission, including development and authoring of responses to Health Authority requests for information as requested by Roche Technical Regulatory
Notify the relevant project teams and Senior Management of potential quality or regulatory issues that may impact project success or timelines
Contribute to development of department goals and remain accountable in order to achieve results. Maintain and communicate work priorities to meet goals and timelines
Ensure on-time completion of all required job training while continuously gaining deeper knowledge and skills in quality, compliance and new technologies
Represent organization as a prime contact on initiatives and projects. Present at functional/cross-functional meetings, to management and project teams on CMO relevant topics.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You have a BA or BSc degree. An MSc, PhD in Chemistry, Biology, Pharmacy, Engineering or other Life Science is preferred. You bring several years of relevant professional experience in a GMP environment within the Pharmaceutical industries.
You bring the following skills and competencies:
Three or more years of validation / qualification experience and/or product launch experience
General knowledge of Quality Systems and Health Authority expectations
Experience in multiple technical platforms (small & large molecules drug substance, drug product, combination products) is a plus
Ability to influence people at different levels and negotiate cross functionally in matrix organizations. Excellent communication skills, strong command of English both verbally and in writing
Strong critical thinking skills. Demonstrated decision-making skills with a pro-active, solution oriented mindset leading to innovative solutions to issues
Strong collaboration skills and a highly self-motivated, well organized working style
This position requires travel up to 25%.
Have we sparked your interest? We then encourage you to submit a cover letter and resume no later than 19 December, 2018.