Salary
💰 $140,000 - $160,000 per year
About the role
- Provide quality oversight of external suppliers and Contract Manufacturing Organizations (CMOs) across both 503A and 503B operations.
- Develop, negotiate, and maintain comprehensive Quality Agreements with all external partners.
- Perform regular audits and assessments to evaluate supplier capabilities and compliance, and follow up with improvement plans, as needed.
- Facilitate data-driven supplier performance reviews with internal and external stakeholders.
- 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 and ensure all supplier qualification documentation is current.
- 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.
- Drive continuous improvement initiatives across the supplier quality program, leveraging tools such as Six Sigma, Lean, or root cause analysis.
Requirements
- Bachelor’s degree in life sciences, engineering, or related field; Master’s degree preferred.
- 8+ years of progressive experience in quality within regulated industries (pharmaceutical, biotech, medical device).
- 5+ years of hands on experience conducting supplier audits, ideally at 503A/503B Pharmacies
- 3+ years of experience overseeing contract manufacturing operations (CMO).
- 3+ years of experience in a managerial role.
- Strong knowledge of global GxP requirements (21 CFR Part 11, USP, ISO 13485, ICH Q10, etc.).
- Strong executive presence with the ability to influence senior stakeholders and decision-makers.
- Professional certifications such as ASQ CQE, CQA, PMP, or Lean Six Sigma Black Belt preferred
- 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.
- Proven success in regulatory inspections (FDA, EMA, ISO) and inspection readiness activities.
- Must be legally authorized to work in the U.S. without restriction (application form asks)