Associate Director, PET Quality Assurance Operations
Lantheus
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $139,000 - $232,000 per year
Job Level
About the role
- Oversee and continuously enhance PET QA Operations program.
- Ensure systems, processes, and procedures are compliant, harmonized, and optimized.
- Collaborate closely with direct reports and cross‑functional partners.
- Plan, organize, and direct all QA Operations activities related to material release, investigations, change management, metrics, batch record review, Annual Product Report reconciliation.
- Develop, maintain, and routinely review Supplier Quality procedures.
- Oversee supplier performance by maintaining key metrics, analyzing trends, and communicating meaningful insights.
- Identify, recommend, and implement enhancements to the Supplier Quality Program.
Requirements
- Bachelor’s degree is required in a related medical, science or engineering discipline.
- Minimum of 10 years’ quality assurance / supplier quality engineering experience in a pharmaceutical environment.
- Excellent written, verbal and presentation skills.
- Must be able to interact effectively with all levels of management.
- Experienced in Positron emission tomography (PET) manufacturing and regulations.
- Good understanding of cGMP requirements by FDA, EMA, and ICH.
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
quality assurancesupplier quality engineeringmaterial releaseinvestigationschange managementmetrics analysisbatch record reviewAnnual Product Report reconciliationSupplier Quality procedurescGMP compliance
Soft Skills
collaborationcommunicationorganizational skillspresentation skillsinterpersonal skillsleadershipanalytical skillsproblem-solving