Quality Excellence Lead

Posted 2 Days Ago
Be an Early Applicant
South San Francisco, CA
In-Office
111K-206K Annually
Senior level
Healthtech • Biotech
The Role
As a Quality Excellence Lead, you will drive quality strategies, manage risks, ensure business continuity, and provide data insights to improve quality processes.
Summary Generated by Built In

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 Quality Excellence Lead to join our Global Quality team, shaping quality strategies, managing critical to quality risks and business continuity, and delivering insights that drive a thriving future for our Quality and Product Development organization.

The Opportunity

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us 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 Quality Excellence Lead, you will play a pivotal role in driving excellence, efficiency and effectiveness across our global quality landscape, from managing Quality risks and business continuity, to quality insights for leadership as well as other excellence initiatives.

Key Responsibilities
  • Act as the PD Quality Risk Manager across PDQ, as a member of the broader Medical Compliance Risk Community; leading risk identification, management and mitigation to de-risk our portfolio, compliance and business risks. 

  • Act as the Business Continuity Planning (BCP) Manager across PDQ, as a member of the Business Continuity Management (BCM) community in PD; building, managing and executing business continuity plans, test scenarios and overall ensuring PDQ BCM compliance.

  • Developing PDQ Performance Insights from PDQ data and other source data, which are presented to the PD Quality Leadership Team (QMLT) to support LT decision making and quality improvements.

  • Lead the development and implementation of strategies to enhance outcomes, productivity, and efficiency across Product Development Quality (PDQ).

  • Manage large-scale projects in international, multicultural matrix environments, ensuring alignment across the business.

  • Apply systems-thinking and strategic collaboration to streamline and accelerate quality outcomes.

Who You Are

Essential Skills and Experience:

  • Strong technical expertise in areas like GCP, GVP, MDR, SaMDs, QMS, or Risk-Based Quality Management (RBQM).

  • Skilled in Risk Management methodologies.

  • Skills and capabilities to support the development and management of business continuity plans.

  • Demonstrated critical thinking, problem-solving, and adaptability in challenging situations.

  • Digital and data-literate, with the ability to apply insights for impactful outcomes.

  • Proven ability to lead large, complex projects while fostering effective decision-making and collaboration.

  • Skilled in stakeholder engagement, influencing, and negotiation.

Competencies You'll Demonstrate:

  • Critical thinking and a proactive risk-based approach.

  • Strategic decision-making aligned with business value.

  • A change mindset and an innovative, data-driven approach.

  • Exceptional communication and collaboration skills.

Your Application:

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 $111,000 to $206,100.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  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.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Top Skills

Data Analysis
GCP
Gvp
Mdr
Qms
Risk-Based Quality Management
Samds
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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years.

Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

Making a difference in the lives of millions starts when you make a change in yours.

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