Supplier Quality Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that supplier activities align with RayzeBio's policies, standards, procedures, and global cGMP regulations.

• Lead the management of material lifecycles, including qualification, change management, non-conformance, and continuous improvement.

• Oversee the qualification and management of vendors related to GMP and GDP.

• Identify and evaluate new vendors, create and update Quality Agreements, and maintain the Approved Vendor List.

• Manage the implementation of material qualification, vendor change notifications, and programs for material non-conformance at the site level.

• Oversee the lifecycle of materials used in the production of starting materials, drug substances, and drug products.

• Provide oversight and review supplier complaints and their corresponding responses.

• Conduct quality assessments of supplier change notifications and ensure actions are completed.

• Support and lead external supplier audits, ensuring that supplier systems comply with regulatory requirements, cGMP standards, and RayzeBio's expectations.

• Evaluate responses to observations, track follow-up actions, and ensure closure.

• Manage discrepancy reporting, deviations, and CAPAs associated with nonconforming vendor materials or services.

• Review and approve SOPs, technical documents, reports, agreements, qualifications, and forms.

• Establish and implement quality oversight processes for on-site service vendors.

• Facilitate meetings with site stakeholders, network locations, and external partners, including discussions, negotiations, and conflict resolution.

• Lead cross-functional meetings and initiatives related to supplier and material activities.

• Act as a core team member during corporate or health authority inspections.

• Identify and report discrepancies to management.

• Lead teams and cross-functional project groups, driving performance and results.

• Contribute to departmental performance and quality initiatives.

• Utilize AI to enhance team execution and decision-making.

• Perform additional QA responsibilities as assigned by QA management.

⛳️ Requirements

• A minimum of a bachelor's degree in engineering or a life or physical science-related field, such as biology, biochemistry, or chemistry.

• At least 5 years of experience in Quality Assurance.

• Preferred experience in managing the quality of suppliers that provide raw materials, consumables, and services for finished product manufacturing.

• Highly preferred experience with material lifecycle management.

• Familiarity with Quality Risk Management principles is advantageous.

• Familiarity with SAP is a plus.

• Knowledge of cGMP regulations and guidance in the US, EU, and other global regions.

• Proven leadership, interpersonal, communication, and motivational abilities.

• Excellent written and verbal communication skills.

• Previous roles requiring a strong attention to detail.

• Well-versed in exercising sound judgment during decision-making.

• Demonstrated skills in prioritization and organization.

• Ability to work in a laboratory setting while using protective clothing, gloves, and safety glasses when handling radioactive materials.

• Capability to occasionally lift and/or move up to 25 pounds.

• Willingness to travel occasionally, not exceeding 5%.

🏝️ Benefits

• Additional discretionary incentive cash and stock opportunities.

• Support for wellbeing.

• Retirement and financial protection benefits.

• Medical, dental, vision, life, and disability insurance options.

• Flexible Time Off (FTO) for exempt employees based in the U.S.

• Eleven paid company holidays each year.

• 160 hours of paid vacation annually for new hires, non-exempt employees, RayzeBio employees, and employees based in Puerto Rico.

• Three optional holidays.

• Paid sick leave, based on eligibility.

• Up to two paid volunteer days each year.

• Flexible summer hours.

• Leave of absence for medical, personal, parental, caregiver, bereavement, or military needs.

• Annual Global Shutdown between Christmas Day and New Year's Day.

• Reasonable workplace accommodations and ongoing support.

• Occasional travel not exceeding 5%.