Global Quality SME - API | Inspections & Compliance Leader

CordenPharma; Boulder (CO); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Life Insurance

Tuition Reimbursement

Wellness Program

Vision Insurance

Disability Insurance

Job summary

CordenPharma is seeking an Associate Director, Global Quality - API to serve as a Global Quality SME for API manufacturing. This role supports GMP compliance, quality systems, and complex operational challenges across the network, with hands-on contributions to global quality initiatives and continuous improvement.

It requires extensive API quality experience, strong regulatory knowledge, and proven ability to lead cross-functional global teams.

Qualifications

• BA/BS in Chemistry, Pharmacy, Engineering or related field; 15 years API quality, manufacturing or QA/QC experience.
• Strong Quality background and extensive experience in API/ CDMO environments.

Responsibilities

• Act as SME for API GMP compliance across global network.
• Support audits, inspections and regulatory expectations.
• Provide expertise on quality systems, process robustness and QbD.
• Advise on quality integration activities (new sites, acquisitions).
• Deliver GMP training and guidance; define Corporate Compliance Standards.
• Support inspection readiness, audits, remediation, CAPAs, and risk mitigation.
• Drive harmonization and continuous improvement of quality systems across sites.

Skills

GMP compliance

Regulatory knowledge

Quality systems

CAPA and investigations

Cross-functional collaboration

Education

BA/BS in Chemistry, Pharmacy, Engineering or related field

Job description

CordenPharma is seeking an Associate Director, Global Quality - API to serve as a Global Quality SME for API manufacturing. This role supports GMP compliance, quality systems, and complex operational challenges across the network, with hands-on contributions to global quality initiatives and continuous improvement.

It requires extensive API quality experience, strong regulatory knowledge, and proven ability to lead cross-functional global teams.