Senior Quality Manager

GlaxoSmithKline • San Francisco, CA

322d • $116,325 - $193,875

About The Position

As part of GSK's ambition to “Supercharge our data capability”, the Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines. We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward: Building a next-generation, metadata- and automation-driven data experience for GSK's scientists, engineers, and decision-makers, increasing productivity and reducing time spent on “data mechanics” Providing best-in-class AI/ML and data analysis environments to accelerate our predictive capabilities and attract top-tier talent Aggressively engineering our data at scale, as one unified asset, to unlock the value of our unique collection of data and predictions in real-time.

Requirements

• Bachelor's degree in Data Management, Biological science, Information security, Engineering or related fields.
• 6+ years of job-related relevant Quality Assurance experience in software products in the Life Sciences sector.
• Knowledge in the areas of Quality Management Systems.
• Experienced in maintaining and implementing risk based quality management processes.

Nice To Haves

• Strong written and verbal communication capabilities, technical writing ability and concise language skills.
• Proven ability to review and assess technical information ensuring delivery of user focused, fit-for-purpose, simple content.
• Team player with demonstrated ability to motivate and work collaboratively with a team of expert staff.
• Flexible and adaptable according to the priorities and needs of the business.
• Global perspective; cultural sensitivity.
• Ability to withstand reasonable pressure, self-motivated with sense of urgency.
• Understands basics of or has background working with data engineering teams, GxP standards, software platforms and data privacy.

Responsibilities

• Provide quality support and oversight during applications and data pipelines development and maintenance.
• Management and monitoring of issues/findings, CAPAs, risks and exceptions.
• Support Internal / External audits - including Audit Readiness activities.
• Support the design, implementation and Maintenance of the Quality Framework operational processes and governance that are fit for purpose.
• Support effective embedding of quality process into Onyx's engineering ways of working that fits modern agile software engineering practice.
• Build strong relationships with stakeholders within and outside of Onyx to allow for effective implementation of processes building a single Onyx quality culture focused at continuous improvement.
• Partner with Onyx team members to facilitate documentation of Onyx-specific processes.
• Monitor deliverable quality, ensure quality standards are being met for products/projects, programs or operations.
• Contribute to providing Project Quality assurance oversight depending on the specific project risk profile.
• Ensure Business Unit activities align with Regulatory requirements and liaise with Business Quality Groups.
• Contribute to ensuring Onyx is keeping up with relevant and applicable regulatory and legal requirements.
• Contribute to identification and initiation of Risk mitigation projects.
• Facilitate risk identification and risk discussions within the business unit.
• Enforce compliance within Tech Policies and Standards as required within Onyx.
• Support Product owners in the management of their project risks.
• Contribute to ensuring Onyx is ready to host external inspections from regulatory bodies.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver/parental and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree