Director of Supplier Quality Management & CDMO Oversight

Lantheus • Bedford, MA

13h • $172,000 - $287,000 • Onsite

About The Position

The Director of Supplier Quality Management & CDMO Oversight is a senior quality leader responsible for establishing and executing the strategy that ensures all external partners—including Contract Development and Manufacturing Organizations (CDMOs), raw material suppliers, packaging vendors, and critical service providers—consistently deliver safe, compliant, and high‑quality pharmaceutical products. This role oversees the full lifecycle of external manufacturing quality, from supplier qualification and governance to ongoing performance monitoring, issue resolution, and continuous improvement.

The director serves as the primary quality interface with CDMOs and key suppliers, ensuring alignment with global cGMP requirements, regulatory expectations, and internal quality standards. This leader drives operational excellence, strengthens supply reliability, and supports successful regulatory submissions and inspections through robust oversight and proactive risk management.

This position is based in Bedford, Massachusetts and requires a presence on-site (two/three) days per week and is open to applicants authorized to work for any employer within the United States.

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.
• Incumbent must have excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management, both internal and external.
• Must have a good understanding of cGMP requirements by FDA, EMA, ICH Q8, 9 and 10 etc.
• Strong negotiating and collaboration skills are essential; incumbent must be able to influence and drive suppliers to high levels of performance.
• Strong analytical and problem solving skills with a risk-based mindset.

Nice To Haves

• Experience with technology transfer, process validation, and commercial product lifecycle management
• Exceptional communication, negotiation, and relationship building abilities.
• Ability to influence at all levels and lead cross functional teams in a matrixed environment.
• Strategic thinker with the ability to balance long term vision and operational execution.

Responsibilities

• 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.
• Serve as the senior quality representative for external manufacturing within cross-functional leadership forums.
• 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.
• Support technology transfers, scale-up activities, and process validation at external sites.
• Lead quality risk assessments for external partners and implement mitigation strategies.
• Drive continuous improvement initiatives across the external supply network to enhance quality performance and reliability.
• Monitor and analyze supplier performance metrics, identifying trends and opportunities for improvement.
• Ensure CDMOs and suppliers are inspection-ready and compliant with global regulatory expectations (FDA, EMA, MHRA, etc.).
• Partner closely with Technical Operations, Supply Chain, Regulatory Affairs, Procurement, and Quality Assurance to ensure seamless external manufacturing operations.
• Develop and maintain a strong partnership with key suppliers and act as the primary conduit for quality related issues from suppliers, contractors and consultants. Partner with Procurement and R&D, at an early stage, to identify development as well as commercial suppliers and contractors for new product introduction programs and redundancy in supply.
• Act as the primary Quality representative for supplier management projects to support cost control programs, inventory management planning and compliance and business risk mitigation programs.
• Oversee and ensure adherence to supplier quality management budget plan

Benefits

• Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award.
• Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director