About this opportunity
CordenPharma lists this Associate Director, Global Quality - API opportunity in boulder, Colorado. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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Associate Director, Global Quality - API
Regular Full-Time Management Boulder, CO, US
$150,000.00 To $170,000.00 Annually
CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
Our People Vision
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
This role may be based in either Boulder, CO or N. Augusta, GA
SUMMARY
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.
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
ESSENTIALDUTIESAND RESPONSIBILITIES
Include 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 EXPERIENCE
BA 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 COMPETENCIES
These 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%)
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
401(k) matching - CordenPharma will contribute 100% of the first 6% - 100% vested after 2 years of service
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
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. Corden Pharma embraces fair hiring practices.
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Worksite address
boulder, CO, 80301, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.