Senior Quality Excellence Lead

Overview

The Position

Are you a highly skilled professional, interested in Quality Excellence, driven by a passion for innovation and a desire to make a tangible impact?

We have a thrilling opportunity for a Senior Quality Excellence Lead to join our Global Quality team.

At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society.

As a Senior Quality Excellence Lead, you will play a pivotal role in driving excellence, efficiency and effectiveness across our global quality landscape, from managing the Quality Portfolio of activities, Quality Strategic Workforce Planning and associated Quality insights for leadership as well as other excellence initiatives.

• Act as the lead for Quality Portfolio Management across Product Development Quality (PDQ), including prioritization and effective resource management to the most Critical to Quality activities.
• Act as the lead for Quality Resource Management, as a member of the wider resource management community in PD; including resource forecasting and allocation decisions.
• Developing Quality Performance Insights from portfolio and resourcing data and other source data, which are presented to the PD Quality Leadership Team to support decision making and quality improvements.
• Lead the design and implementation of Quality Excellence strategies to enhance outcomes, productivity, and efficiency across Product Development Quality (PDQ).
• Proactively identifies and implements innovative tools and technologies for continuous improvement.
• Coordinates or leads teams, projects, and initiatives, including mentoring and coaching others.
• Apply systems-thinking and strategic collaboration to streamline and accelerate quality outcomes.

Essential Skills and Experience

• Strong technical expertise in areas like GCP, GVP, MDR, SaMDs, QMS, or Risk-Based Quality Management (RBQM).
• Proven ability to build effective relationships with partners and stakeholders to promote alignment and collaboration on quality initiatives, and experience working in cross-functional environments.
• Strong communication skills for engaging with internal and external stakeholders.
• Leads cross-functional teams to identify and address quality-related challenges, ensuring that strategic objectives are met and quality outcomes are optimized.
• Contributes to the realization of strategic outcomes and vision.

• Strong digital and data literacy
• Skilled in using and analyzing data to drive solutions
• Business ownership of computerized systems
• Ability to create highly effective visualizations to help assimilate data insights and enable actions and/or decision-making
• Advanced communication and presentation skills
• Strong stakeholder management and engagement skills
• Comfortable working with ambiguous and complex information and able to synthesize it into clear and concise points of view to influence decision-making and action-taking
• Ability to influence with and without authority, and negotiate effective solutions
• Proven critical thinking, analytical, problem-solving, and decision-making skills
• Ability to work effectively in an international, multicultural matrix organization and as part of agile project teams. Demonstrates effective teamwork and collaboration skills
• Experienced in leading global project teams, and strong project management skills
• Strong organizational and execution skills, and demonstrated ability to work independently and proactively

• Significant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP,GVP, IVD/MD Regulations).
• Bachelor's degree or equivalent in a scientific or quality-related field or equivalent combination of education, training, and experience.
• Advanced degree in referenced fields preferred.
• Understanding of product development-related global GxP regulatory requirements (e.g., GCP, GVP, IVD/MD Regulations) and processes.
• Exposure to GCP/GVP/IVD/MD Quality roles.
• Good understanding of Information Systems, e.g., audit management and analysis reporting tools.
• Understanding of business operations and strategies.
• Fluency in written and spoken English; bi or multi-lingual skills are desirable.

Please kindly provide a cover letter alongside your CV.

The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $141,000 to $261,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary…