Associate Director, API Supplier Quality Management

Employer Industry: Pharmaceutical Manufacturing Why consider this job opportunity:

• Salary up to $169,400
• Eligibility for a company bonus based on individual and company performance
• Comprehensive benefits package including 401(k), pension, medical, dental, and vision coverage
• Opportunities for professional growth and skill development within a global healthcare leader
• Supportive work environment that prioritizes employee well‑being and community engagement
• Chance to work with innovative drug products and technologies that make a meaningful impact on patient lives

• Lead the qualification and quality oversight of contract manufacturers and associated suppliers
• Design and enhance the risk‑based precursor program and update procedures to align with corporate quality standards
• Manage quality distribution activities for precursor and reference standards
• Collaborate with cross‑functional teams and contract manufacturing partners to resolve manufacturing issues
• Develop and maintain supplier quality agreements and coordinate audit scheduling

• Bachelor’s degree, preferably in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry
• Minimum 5 years of experience in pharmaceutical manufacturing or Quality Assurance
• Strong knowledge of commercial and investigational drug product quality management
• Familiarity with global GMP regulations and ability to interpret and apply them
• Proven experience in API manufacturing validation and analytical method validation

• Strong chemistry background in API production
• Experience in writing and revising Quality Agreements
• Proficient in root cause analysis and quality assessment of CAPA Plans
• Demonstrated negotiation and influence skills
• Knowledge of radiopharmaceutical manufacturing GMPs

#Pharmaceutical Manufacturing #Quality Assurance #Career Growth #Healthcare Innovation #Employee Benefits

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