Associate Director, Global Quality - API

About the role

In this role, you act as a Global Quality Subject Matter Expert (SME) for API manufacturing, supporting sites across the network in GMP compliance, quality systems, and complex operational challenges. You work closely with local and global teams to ensure inspection readiness, robust processes, and consistent quality standards, while contributing hands-on to global quality initiatives and continuous improvement.

Essential Duties And Responsibilities

• Expert / Advisory (Focus)
• Act as SME for API GMP compliance (EU & FDA) across the global network
• Support sites on complex quality topics, audits, and regulatory expectations
• Provide expertise on quality systems, process robustness, and QbD principles
• Advises on and execute quality integration activities (e.g. new sites, acquisitions)
• Create and implement Corporate Compliance Standards
• Operational Support
• Inspection readiness, audits, and remediation activities
• Monitor KPIs and identify risks, driving appropriate corrective actions
• Participate in quality escalations and ensure structured investigations & CAPAs
• Collaborate with sites on quality agreements and customer interactions
• Drive harmonization and continuous improvement of quality systems across sites

Education And/or Experience

• Bachelor's or Master's degree (scientific degree preferred) in Chemistry, Pharmacy, Engineering or related field from a four-year university; and 15 years’ experience in API quality, manufacturing or QA/QC; or equivalent combination of education and experience.

CORE COMPETENCIES

• Strong expertise in EU GMP & FDA regulations
• Hands-on experience with inspections, audits, and global quality systems
• Proven track record as SME in API or CDMO environment
• Strong stakeholder management and ability to work cross-functionally in global teams
• Willingness to travel internationally (~40%)

Benefits

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

Equal Opportunity Employer

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.