GMP Validation & Regulatory Expert - API Manufacturing

Skills Alliance Enterprise; Cleveland (OH); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

None

Job summary

Skills Alliance Enterprise in the United States is seeking a senior professional to lead GMP regulatory and validation activities for API manufacturing. You will guide compliance, validation strategy, and documentation, coordinating with QA, Manufacturing, Regulatory Affairs, IT, and Technical Operations to ensure inspections readiness.

Ideal candidates have 8–15+ years in pharma/biotech, deep ICH Q7 knowledge, and proven audit experience.

Qualifications

• 8–15+ years in pharma/biotech with GMP API manufacturing, regulatory affairs, and validation experience.
• Deep knowledge of ICH Q7 and related guidelines; regulatory inspections/audits experience.
• Experience with API process development, scale-up, and transfer to GMP facilities.
• Experience with validation master plans, risk-based validation strategies, and OOS/OOT investigations.
• Knowledge of data integrity concepts (ALCOA, 21 CFR Part 11).

Responsibilities

• Provide GMP regulatory and compliance guidance to pharmaceutical manufacturing operations.
• Develop, review, and approve validation strategies, protocols, reports, and related documentation.
• Support equipment, facility, process, cleaning, computer system, and analytical method validation.
• Conduct GMP audits, gap assessments, risk assessments, and remediation programs.
• Support FDA and other regulatory inspections, including preparation, response, and remediation.
• Review deviations, investigations, CAPAs, change controls, and other quality-system records.
• Ensure validation activities comply with 21 CFR Parts 210/211, applicable FDA guidance, EU GMP, ICH, and company procedures.
• Prepare regulatory and quality documentation and provide technical recommendations to management.
• Support continuous improvement and inspection-readiness initiatives.

Skills

GMP regulatory knowledge

Regulatory inspections experience

Quality systems understanding

Cross-functional collaboration

Project management

English fluency

Education

Advanced degree in Chemistry/Pharmaceutical Sciences/Chemical Engineering

Tools

CSV validation tools

CAPA tracking systems

Job description

Skills Alliance Enterprise in the United States is seeking a senior professional to lead GMP regulatory and validation activities for API manufacturing. You will guide compliance, validation strategy, and documentation, coordinating with QA, Manufacturing, Regulatory Affairs, IT, and Technical Operations to ensure inspections readiness.

Ideal candidates have 8–15+ years in pharma/biotech, deep ICH Q7 knowledge, and proven audit experience.