Global API Quality SME & Compliance Leader

Cordenpharma; Hygiene (CO); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

401(k) matching

Critical Illness Insurance

Disability Insurance

Employee Assistance Program

Flexible Spending Account

Health Insurance PPO/HSA

Hospital Indemnity Plan

ID Theft Protection

Life Insurance

Tuition Reimbursement

Wellness Program

Vision Insurance

Job summary

CordenPharma is seeking an Associate Director, Global Quality - API to lead GMP compliance and quality systems across the API network. Based in Boulder, CO, you will partner with sites worldwide to ensure inspection readiness, robust processes, and continuous improvement in quality across all products.

You will bring 15+ years of API quality, manufacturing, or QA/QC experience, with strong EU GMP and FDA knowledge, and a proven track record as SME in CDMO environments. Travel ~40% is required.

Qualifications

• BA or BS (scientific degree) and 15 years’ API quality, manufacturing or QA/QC experience.
• Strong EU GMP & FDA regulations knowledge.
• Proven SME in API or CDMO environment.
• Experience with inspections, audits, and global quality systems.
• Willingness to travel internationally (~40%).

Responsibilities

• 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.
• Advise on and execute quality integration activities (e.g. new sites, acquisitions).
• Deliver training and guidance on GMP standards and best practices.
• Create and implement Corporate Compliance Standards.
• Support inspection readiness, audits, and remediation activities.
• Monitor KPIs and identify risks, driving corrective actions.
• Participate in quality escalations and CAPAs.
• Collaborate with sites on quality agreements and customer interactions.
• Drive harmonization and continuous improvement of quality systems across sites.

Skills

EU GMP knowledge

FDA regulations

Quality systems

Inspections & audits

Stakeholder management

Cross-functional collaboration

Global teams

Travel ability

Education

BA/BS in Chemistry, Pharmacy, Engineering or related

Job description

CordenPharma is seeking an Associate Director, Global Quality - API to lead GMP compliance and quality systems across the API network. Based in Boulder, CO, you will partner with sites worldwide to ensure inspection readiness, robust processes, and continuous improvement in quality across all products.

You will bring 15+ years of API quality, manufacturing, or QA/QC experience, with strong EU GMP and FDA knowledge, and a proven track record as SME in CDMO environments. Travel ~40% is required.