Director of Supplier Quality Management – CDMO Oversight
Lantheus
full-time
Posted on:
Location Type: Hybrid
Location: Bedford • Massachusetts • United States
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Salary
💰 $172,000 - $287,000 per year
Job Level
About the role
- Lead the Supplier Quality Management function for Lantheus, setting a clear vision, strategy and process for the harmonized quality management of suppliers, contractors and consultants.
- Develop and execute the global Supplier Quality and CDMO oversight strategy aligned with corporate quality objectives.
- Establish and lead a comprehensive external quality governance model, including Quality Business Reviews, performance scorecards, and risk-based oversight plans.
- Oversee the qualification, approval, and periodic re-evaluation of CDMOs, raw material suppliers, and service providers.
- Ensure quality agreements are established, maintained, and effectively implemented.
- Provide quality oversight for all externally manufactured drug substances, drug products, intermediates, and clinical supplies.
- Ensure robust management of deviations, investigations, CAPAs, change controls, and batch disposition activities.
- Partner with CDMOs to ensure process robustness, data integrity, and adherence to cGMP and regulatory requirements.
Requirements
- Requires a Bachelor’s degree in a scientific discipline and minimum of 8-10+ years proven experience managing CDMOs and global suppliers in a cGMP environment within the Pharmaceutical, Biotech and/or Medical Device industry.
- Minimum of 5 years people management experience preferred.
- Excellent written, verbal and presentation skills.
- Must have a good understanding of cGMP requirements by FDA, EMA, ICH Q8, 9 and 10 etc.
- Strong negotiating and collaboration skills.
Benefits
- Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
- Life and disability benefits.
- Pre-tax accounts.
- 401(k) with company contribution.
- Generous time off package including paid vacation, holidays, sick days, and paid parental leave.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Supplier Quality ManagementCDMO oversightQuality Business Reviewsperformance scorecardsrisk-based oversightdeviations managementinvestigations managementCAPAschange controlsbatch disposition
Soft Skills
people managementwritten communicationverbal communicationpresentation skillsnegotiating skillscollaboration skills