Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards.

In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data analytics and digital tools, you will help optimise data collection and provide key insights that directly support our mission of delivering life-changing medicines to patients faster and more securely.

Key Responsibilities:

• Implement Quality Strategies: Support the design, execution, and tracking of risk-based quality management strategies across the PDQ portfolio.

• Deliver Quality Assurance: Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems.

• Manage Quality Data: Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs.

• Present to Health Authorities: Demonstrate the effective implementation of quality strategies.

• Drive Compliance Projects: Participate in departmental or cross-functional compliance initiatives aimed at optimising daily operations.

• Champion Innovation: Drive the adoption of innovative digital tools and technologies into daily workflows to foster a proactive quality culture.

• Foster Collaboration: Build and maintain an inclusive, supportive work environment while executing departmental goals and initiatives under limited supervision.

• Process Mapping: Support process mapping activities to enable the documentation and visualization of simple workflows within the QMS.

• Inspection Support: Provide logistical and compliance support for GxP inspections, including scribe duties and back-room document QC.

You are a proactive, organised professional looking to elevate your career in quality management within a global, life-changing industry. You thrive in environments that value continuous learning, offer room for professional growth, and empower you to work independently to make a genuine impact on patient outcomes.

To be successful in this role, you bring:

• A Bachelor’s degree in a scientific or quality-related discipline, or an equivalent combination of education and experience.

• Experience within the pharmaceutical, biotech, or medical device industry, with a foundational understanding of product development and GxP regulations (e.g., GCP, GVP, MDR).

• Strong digital and data literacy, with the ability to interpret data and translate it into actionable quality insights.

• Exceptional organisational and execution skills, alongside a demonstrated ability to take ownership of projects proactively.

• Developing expertise in Critical to Quality (CtQ) factors and functional group operations.

• Fluency in written and spoken English, with strong presentation skills.

Please note this role is based at our South San Francisco, CA campus. Onsite presence is required.

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 $89,100 - $165,500.  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.

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