Salary
💰 $110,000 - $135,000 per year
About the role
- Execute and maintain supplier quality processes that align with company standards, industry best practices, and applicable regulations.
- Perform regular audits and assessments to evaluate supplier capabilities and compliance, and follow up with improvement plans, as needed.
- Collaborate with suppliers and internal stakeholders to investigate and resolve quality issues using structured root cause analysis and corrective action methodologies.
- Establish, monitor and report on key supplier quality metrics.
- Monitor suppliers’ compliance status with regulators and maintain up-to-date supplier qualification documentation.
- Partner with Sourcing and R&D during early development phases to support new product introductions and ensure supplier quality readiness.
- Identify and escalate quality concerns and risks in the supply chain using structured risk management processes.
- Maintain comprehensive documentation of supplier qualifications, deviations, corrective actions, and other quality-related records, and ensure timely reporting to internal teams.
Requirements
- 5+ years of hands-on experience conducting supplier audits, ideally at 503A pharmacies and 503B outsourcing facilities.
- Experience in supplier quality, manufacturing quality, or a related field within regulated industries such as pharmaceuticals, medical devices.
- A bachelor’s degree in Engineering, or a related technical discipline. Professional certifications such as ASQ Certified Auditor or Certified Quality Engineer are a plus.
- Proficiency in quality systems and standards including 21 CFR Part 210/211, USP <795> and <797>
- A track record of successfully resolving complex quality issues using structured problem-solving approaches.
- Strong communication, negotiation, and interpersonal skills that enable effective collaboration with both suppliers and internal cross-functional teams.
- Experience managing multiple projects and tasks simultaneously with high attention to detail and effective coordination across departments.
- Ability and willingness to travel domestically and internationally up to 30% for supplier audits, and company meetings.