Senior Quality Excellence Lead jobs in United States
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Genentech · 9 hours ago

Senior Quality Excellence Lead

Genentech is committed to quality in Pharma Development, and they are seeking a Senior Quality Excellence Lead to join their Global Quality team. This role involves driving excellence, efficiency, and effectiveness across global quality initiatives, managing the Quality Portfolio, and providing insights for leadership decision-making.

BiotechnologyLife ScienceManufacturing
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

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
Leads 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

Qualification

GCPGVPQMSRisk-Based Quality ManagementData analysisProject managementStakeholder managementFluency in EnglishCommunication skillsTeam collaborationCritical thinkingProblem-solving

Required

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 has 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
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

Preferred

Advanced degree in referenced fields preferred

Benefits

A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.

Company

Genentech

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Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.

H1B Sponsorship

Genentech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)

Funding

Current Stage
Public Company
Total Funding
unknown
2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown

Leadership Team

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Ashley Magargee
Chief Executive Officer
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Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
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Company data provided by crunchbase