Associate Director, Global Quality - API

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

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.