This role may be based in either Boulder, CO or N. Augusta, GASUMMARYIn 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.
What makes this role relevant:- Strong expert role with global exposure across API sites
- High impact on compliance, inspections, and quality systems
- Focus on hands-on support, problem-solving, and continuous improvement
ESSENTIAL DUTIES AND RESPONSIBILITIESInclude the following. Other duties may be assigned.
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
- 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.
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 EXPERIENCEBA or BS (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. Strong Quality background and experience is a must
CORE COMPETENCIESThese are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- 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%)
SALARYActual pay will be based on your skills and experience.
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
