Global API Quality SME & Compliance Leader

Corden Pharma - A Full-Service CDMO; Boulder (CO); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

401(k) matching

Health insurance PPO/HSA

Tuition reimbursement

Vacation – Three weeks

Life insurance

Paid parental leave

Wellness program

Job summary

CordenPharma is seeking a Global Quality Subject Matter Expert (SME) for API manufacturing to support GMP compliance and quality systems across its global network. The role emphasizes hands-on support, inspections, and continuous improvement while collaborating with local and global teams.

Requirements include a scientific BA/BS and 15 years in API quality, manufacturing, or QA/QC, with travel ~40% and a strong track record as an SME in a CDMO environment.

Qualifications

• BA or BS (scientific degree) in Chemistry, Pharmacy, Engineering or related field from a four-year university.
• 15 years’ experience in API quality, manufacturing or QA/QC; or equivalent combination of education and experience.
• Strong quality background and experience is required.

Responsibilities

• Act as SME for API GMP compliance (EU & FDA) across the global network.
• Provide expertise on quality systems, inspections, audits, and regulatory expectations.
• Advise on quality integration activities (new sites, acquisitions) and CAPAs.
• Deliver training and guidance on GMP standards and best practices.

Skills

EU GMP regulations

FDA regulations

Audits & inspections

Quality systems

QbD principles

Stakeholder management

Global collaboration

Education

BA/BS in Chemistry or Pharmacy or Engineering

Job description

CordenPharma is seeking a Global Quality Subject Matter Expert (SME) for API manufacturing to support GMP compliance and quality systems across its global network. The role emphasizes hands-on support, inspections, and continuous improvement while collaborating with local and global teams.

Requirements include a scientific BA/BS and 15 years in API quality, manufacturing, or QA/QC, with travel ~40% and a strong track record as an SME in a CDMO environment.