GMP Validation Consultant

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

A global science and tech company with a legacy of using science as a force for good. Fueled for the future, leveraging expertise to address unmet medical needs and impact the lives of the patients that rely on them. Our client aspires to create, improve and prolong life for people living with difficult-to-treat conditions.

Key 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.
• Partner with Quality, Manufacturing, Engineering, Regulatory Affairs, IT, and Technical Operations.
• Prepare regulatory and quality documentation and provide technical recommendations to management.
• Support continuous improvement and inspection-readiness initiatives.

Qualifications

• 8–15+ years in pharma/biotech with a significant portion focused on GMP API manufacturing, regulatory affairs, and validation.

Regulatory and GMP expertise

• Deep working knowledge of ICH Q7 (GMP for APIs) and related ICH guidelines (Q8–Q11, Q9 quality risk management, Q10 pharmaceutical quality system).
• Practical experience with regulatory inspections/audits (FDA, EMA, PMDA, etc.) and CAPA handling.
• Familiarity with global API regulatory pathways, registration, and maintenance activities for major markets.

API development and manufacturing

• Track record in API process development, scale-up, and transfer to GMP manufacturing facilities.
• Experience with batch release, qualification/validation of manufacturing processes, and technology transfer.
• Knowledge of serialization, supply chain controls, and API integrity requirements.

Validation and lifecycle management

• Design, execution, and interpretation of process validation, cleaning validation, and analytical method validation/verification.
• Experience with commissioning, qualification (IQ/OQ/PQ), and continued process verification.
• Proficiency in developing validation master plans (VMP), risk-based validation strategies, and OOS/OOT investigations.

Quality systems and compliance

• Strong grasp of GMP, quality systems, deviation and CAPA management, change control, and document control.
• Experience with vendor qualification, PQ/CV of third-party manufacture, and supplier audits.
• Knowledge of computer systems validation (CSV) and data integrity concepts (ALCOA, 21 CFR Part 11 considerations).

Analytical and technical competencies

• Understanding of analytical chemistry methods used for API characterization and impurity profiling.
• Ability to interpret GMP-relevant data, perform risk assessments, and apply ICH Q11/Q12 concepts.

Project leadership and cross-functional collaboration

• Proven ability to lead cross-functional teams (R&D, QA, Manufacturing, Supply Chain, Regulatory) on complex API programs.
• Strong project management, planning, and budgeting skills; decisive decision-maker with effective communication.

Other

• Problem-solving mindset, risk-based thinking, and ability to travel for audits/inspections as needed.
• Fluency in English (and other languages as a plus)
• Ability to write clear, accurate, structured documents such as SOPs, work instructions, batch records, protocols, reports, deviations, CAPAs, and change controls.
• Ability to translate complex technical information into clear, compliant, user-friendly documentation.

Certifications and preferred credentials

• Regulatory Affairs Certification (RAC) or equivalent regulatory affairs/quality certifications.
• GMP/quality auditing credentials or CQV experience are a plus.

Education

• Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field (BS with extensive experience can suffice; MS/PhD preferred).