Chapter Lead Clinical Collaboration

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The Position

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As the Chapter Lead, Clinical Quality, you will be a member of the Premarket Quality Leadership Team.  You are accountable for providing quality partnership to Clinical Development and Medical Affairs (CDMA) and the Diagnostics Clinical Testing Laboratories to ensure seamless integration with other QMS activities and to ensure compliance with internal and external requirements.  You will provide leadership to the team within your Chapter and support a holistic approach to quality by partnering with other functions, by being focused on patient impact and by continually increasing our impact value. 

The Opportunity

• You ensure that Roche Diagnostics’ capabilities in Clinical Quality thrive by leveraging a consolidated view of the Chapter’s capabilities to represent the most senior level of specialized expertise in Clinical Quality towards CDMA, Clinical Testing Labs, and other Functions.

• You maintain and develop all assets and partnerships related to Clinical Quality that are owned by Roche Diagnostics, such as modular QMS processes and associated tools for activities relevant to CDMA and Clinical Testing Laboratories. 

• You ensure a data centric approach for medical risk assessment and ensure consistent application of clinical risk in QMS processes.  You develop and deploy modular QMS processes for areas relevant to CDMA. You Provide quality support for Clinical Trial and Study activities including Clinical Supplier Audits, BIMO inspections, review and approval of relevant clinical trial protocols/deviations/data.

• You manage all aspects of the Clinical Laboratory QMS, laboratory operations quality, new test development quality,  permits/licenses and accreditations, and external audits.You partner with the Customer Area to manage Pharma Partner Quality support including, but not limited to, external audit and relationship management.

• You serve as an active coach and mentor to members of the Chapter to help them grow and progress in their career.  You nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the Chapter with the capabilities to support Roche Diagnostics’ efforts of best-in-class expertise.

• You work closely with Premarket Quality Networks, CDMA and Premarket Quality Chapters to identify and translate strategic direction to capability needs. 

Who You Are

• You have an advanced degree in a relevant field.

• You have 10+ years of experience in the diagnostics industry or a related field in a business related function.

• You have deep/broad knowledge in regulated products (IVD/MD or Pharmaceuticals), clinical development processes (ICH E6 (R2), ISO 20916, and/or IVDR, 21 CFR 812)

• You have deep/broad knowledge of clinical testing laboratory requirements and regulations (CLIA, CAP, ISO 15189, NY CLEP, California business code, and other local and national regulations)

• You have deep/broad knowledge of requirements and regulations governing use of clinical testing data in pharmaceutical trials

• You have strong business and financial acumen with an enterprise mindset.

Knowledge, Skills & Abilities

• You have strong leadership and people development experience with proven ability to inspire and motivate teams to make a big impact and deliver their best every day.

• You demonstrate courage, vision and drive to be at the forefront of innovative change.

• You have a consistent record of building collaborative relationships with peers and teams, helping cross-functional teams address strategic opportunities and solve problems across the organization.

• You have strong strategic thinking, communication, planning and organizational skills required, e.g., through experience successfully leading strategic initiatives.

• You can foster positive partnerships through effective influencing, negotiation and conflict management skills to achieve alignment up and down the organization.