Job Title: Senior Quality Engineer

Location: South San Francisco

About Us

Soley Therapeutics is a biotechnology company that was created with the belief that drug discovery and development should be faster and less expensive, with a much higher probability of success. To achieve this goal, we are pioneering a novel, fully integrated approach that combines data and machine learning insights at every step of the process. We are a multi-disciplinary team that brings together experts in drug development, data engineering, and machine learning to create a cohesive platform. Our end goal is to create life-changing medical treatments by combining expertise in technology and life sciences with a comprehensive view of the entire drug discovery and development process.

Soley Therapeutics is committed to hiring a world-class team that brings together a wide variety of different skills and experiences. We are committed to inclusion across race, gender, age, religion, identity, and experience, and believe that diversity makes us stronger by bringing in new ideas and perspectives. We strive to create a workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

About the Role

Soley is hiring a self-motivated, experienced and detail-oriented Senior Quality Engineer to join our fast-growing drug discovery company. The Senior Quality Engineer will be responsible for overseeing and ensuring quality and compliance of company's operations related to drug discovery processes.

What You’ll Do…

· Develop, implement, and maintain an effective Quality Management System (QMS) to meet regulatory requirements and industry standards.

· Stay up-to-date with relevant regulations and guidelines from regulatory bodies like Food and Drug Administration (FDA) and European Medicines Agency (EMA). Ensure that company's processes, documentation and systems comply with these regulations and other standards like International Organization for Standardization (ISO).

· Establish and enforce QA procedures and standards across the organization.

· Implement robust document control systems to manage and maintain controlled documents, including Standard Operating Procedures (SOP’s), protocols, records, etc.

· Promote a culture of World-Class Quality throughout the organization.

· Work closely with Automation and Life Science teams to collect and analyze results from various QC Tests to evaluate accuracy and repeatability of the automation and lab equipment used in drug discovery processes.

· Develop and monitor Key Performance Indicators (KPI’s) to track quality metrics. Identify opportunities for Continuous Improvements and Process/Efficiency Optimization.

· Manage Quality Events to address Nonconformances. Work with all internal and external stakeholders on Root Cause Analysis and Corrective Actions and drive them to closure.

· Develop and deliver training programs to ensure employees understand and adhere to quality standards, procedures and regulatory requirements.

· Conduct regular audits and assessments to identify areas for improvement and address any non-compliance issues.

· Prepare the company for regulatory inspections and audits by maintaining inspection readiness, coordinating inspections and providing necessary support during the process.

· Implement a Risk Management framework to identify, assess and mitigate risks associated with drug discovery processes. Foster a culture of Risk Awareness.

· Collaborate with Automation and Life Science teams to engage with suppliers to ensure high Quality and Reliability for materials and equipment as needed.

· Perform other related duties as assigned.

What You Bring…

· 7+ years of experience in Quality Assurance/Quality Control roles within life science, pharmaceutical or biotechnology industry, preferably in drug discovery.

· Experience with automation for drug discovery processes required.

· In-depth understanding of International Organization for Standardization (ISO) requirements and regulatory requirements for Food and Drug Administration (FDA) and European Medicines Agency (EMA).

· Familiarity with Current Good Practice (cGxP) guidelines. For example, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).

· Experienced in establishing and maintaining robust Quality Management Systems (QMS).

· Good track record of putting Design of Experiments (DOE), Statistical Process Control (SPC), Lean Six Sigma, Root Cause Analysis (RCA) and Corrective & Preventive Actions (CAPA) into practice.

· Extensive experience in leading internal and external audits and inspections.

· Strong analytical skills with the ability to analyze data, draw conclusions and make recommendations for improvements.

· Excellent written and verbal communication skills.

· Strong leadership skills to promote concepts like Foolproof Process (Poka-Yoke) and Continuous Improvements throughout the organization.

· Ability to work independently and as part of a team.

· Strong attention to detail.

· Good computer skills including proficiency with Microsoft Office.

· Bachelor’s degree in Science (e.g. Chemistry, Biology, Pharmacy, etc.), Engineering or related fields.

Soley Therapeutics

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Senior Quality Engineer