Compliance Specialist (Pharmaceuticals)

TL;DR

Compliance Specialist (Pharmaceuticals): Supporting quality compliance, inspection readiness, and data integrity within a GMP-regulated pharmaceutical manufacturing environment with an accent on internal audits and regulatory inspections. Focus on managing CAPAs, conducting data integrity risk assessments, and promoting a strong quality culture across the site.

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across 60 countries.

What you will do

• Serve as a Compliance Partner for assigned departments to support inspection readiness initiatives.
• Coordinate logistics, documentation, and stakeholder communication for regulatory inspections and external audits.
• Implement and conduct site-wide Data Integrity training and risk assessment (DIRA) programs.
• Perform internal GMP audits and manage the full audit lifecycle, including CAPA follow-up.
• Collaborate with Manufacturing, Engineering, and Validation teams to ensure alignment with regulatory expectations.
• Maintain and revise quality system documentation in accordance with site procedures and GMP requirements.

Requirements

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or Chemistry.
• At least 6 years of Quality Assurance experience within GMP-regulated pharmaceutical, biologics, or API manufacturing environments.
• Strong knowledge of GMP requirements, Quality Systems, and CAPA management.
• Deep understanding of Data Integrity principles, Data Governance, and Audit Trail Review.
• Proven experience supporting internal audits and regulatory inspections.
• Strong technical writing and stakeholder management skills.

Nice to have

• Familiarity with GMP systems such as DeltaV, MES, SAP, or LIMS.
• Understanding of engineering operations and OT/IT system interfaces in regulated environments.

Culture & Benefits

• International work environment with a global team spread across 5 continents.
• Focus on professional growth and nurturing a top talent community.
• Opportunity to work on major international projects through a consulting model.

Hiring process

• Initial brief virtual or phone screening call.
• Series of interviews (averaging 3) with line managers and team members.
• Potential case study or technical assessment depending on the specific role requirements.