As the iNeST Genomic, Bioinformatic & Bio-specimen (GB2) Quality Manager you belong to Global Technical Development Quality in Pharma Technical Operations. More specifically, you will be part of a dedicated cross-functional team working on the development and manufacture of i
herapy (iNeST) products, working very closely with external partners internationally as well as internally with stakeholders in the Clinical and Research (gRED) organizations.
In this position, you provide expertise and guidance to develop, implement and execute on a novel quality framework focusing on the neoantigen selection process. In collaboration with technical experts, you define the necessary set of quality requirements that governs activities related to Bio-specimen collection, Next Generation Sequencing (NGS) and Bioinformatic workflows. You ensure that those elements are integrated within the new Roche Pharmaceutical Quality System and are properly implemented as part of the iNeST product manufacturing process, either internally or at external contract organizations.
In this challenging role, you will:
- Drive the development, implementation and communication of the fit- for- purpose GB2's Quality requirements for iNeST products and ensure cross-functional (e.g. Regulatory, Technical SMEs) alignment and coordination
- Contribute to the implementation of compliant internal Roche capabilities for GB2 activities applicable to both clinical and commercial neoantigen-specific programs
- Partner with the Individualized Therapies GB2 team and Roche Global Quality groups to ensure compliant selection and pragmatic qualification of Contract Development & Manufacturing Organizations (CDMO) for Bio-specimen collection, NGS and bioinformatics workflow processing.
- Define and establish Quality Agreements and provide Quality oversight for selected GB2 CDMOs
- Perform quality risk assessments, develop mitigation plans, and follow-up on implementation progress
- Monitor emerging regulations globally to ensure that neoantigen selection processes maintain and gain compliance with those regulations
- Provide timely support for Health Authority interactions and author/review responses to relevant Health Authority information requests
- Represent the quality assurance function for GB2 to external audiences, participate in industry benchmarking and networking
- Develop and maintain collaborative relations with external partner companies, as well as with other key internal partners within Roche Pharma Development, Pharma Technical and gRED to ensure effective communication and foster positive collaborations
Who you are
You have a Bachelor's or postgraduate degree in Life Sciences, Pharmacy or equivalent and additional qualification or certification in cGMP. You bring at least 7 years of experience in the biopharmaceutical industry and ideally have managed Quality activities across multiple quality system requirements (e.g. Pharmaceuticals and Devices, or Pharmaceutical and Diagnostic). In addition, you are familiar with Next Generation Sequencing (NGS) technology and software as a medical device (SaMD). You also have demonstrated impact in leading strategic quality activities for development programs from early stages through market launch.
You bring the following qualifications and competencies:
- Familiar with multiple sets of regulations and quality standards: cGMP, 21 CFR 820, ISO 13485, CLIA, CAP, NYSDOH, ISO 15189, ISO 62304, PIC/S, ICH, WHO...
- Strong collaboration and teamwork skills
- Excellent influencing-without-authority and negotiating skills when interacting with internal and external stakeholders at all levels within Roche worldwide operations, partner organizations and international regulatory agencies
- High flexibility and strong problem solving capabilities to meet business objectives. A 'can-do' attitude, with the ability to deal with ambiguity and to "think out of the box" and challenge the status quo
- Autonomous with ability to manage complex situations successfully as well as to coordinate multiple tasks and manage priorities to deliver on optimum results
- High intercultural awareness and experience in working across countries and company cultures
- Excellent verbal and written communication skills including the ability to present both strategic objectives and tactical actions clearly and concisely
- Fluent (written and spoken) in English, German language is a strong plus.
This position may require up to 30% travel and will be based out of or South San Francisco (USA) preferably, or Basel (CH)