GMP Compliance & Inspection Readiness Manager

GMP Compliance & Inspection Readiness Manager

Sopharma AD | Quality, GMP & Regulatory Compliance Department | Sofia, Bulgaria

We are looking for an experienced quality professional to lead one of our most important processes: keeping the company ready for regulatory inspections and audits at all times. If you know GMP well, like building systems that work and know how to lead a team, we would be glad to meet you.

About the role

You will make sure the organization is ready for internal and external inspections and audits. You will develop and roll out group-wide GMP policies and standards, and you will manage supplier qualification. You will work directly with regulatory authorities, international auditors and our group companies. You will report to the Director GMP & Regulatory Compliance and lead a team of experts.

Location: Sofia, Bulgaria

Key responsibilities

• Organize and oversee inspection readiness activities, and coordinate preparation for regulatory inspections (BDA, EMA, FDA and others)
• Lead internal and external audits.
• Manage the qualification and validation of suppliers: active substances and excipients, critical starting and packaging materials, finished dosage forms, and services
• Develop, implement and update group policies, global procedures and standards
• Oversee how the group cleaning validation policy is applied
• Build and develop knowledge-sharing processes across the group
  • Lead and develop the team: set objectives, assess performance, find training needs and take part in recruiting and onboarding new team members

What we are looking for

• University degree in Pharmacy, Chemistry, Biotechnology or a related field
• At least 5 years (10 years is un advantage) of experience in the pharmaceutical industry, in Quality Assurance or Quality Control
• At least 2–3 years of people management experience
• Hands-on experience with regulatory inspections, audits and supplier qualification
• Strong knowledge of EU GMP, ICH Q7, Q9 and Q10, CAPA and quality risk management
• Fluent English, written and spoken. English is the everyday working language in this role. You will run audits and inspections in English, work with international suppliers, auditors and group companies, and write group procedures and documentation in English. You will also work with EMA, FDA and ICH guidelines in the original. 
• Strong leadership and organisational skills, analytical thinking and excellent communication
• A proactive approach and the ability to stay focused and calm under pressure

What we offer

• A key role with real influence on quality standards across the group
• Involvement in international projects, audits and initiatives within the group
• A clear path to senior quality leadership or to group and corporate-level roles
• The chance to specialise in regulatory affairs, validation or risk management
• Ongoing training, certifications and professional development
• Competitive pay and additional benefits
• Work at one of Bulgaria’s leading pharmaceutical companies

How to apply

Please send your CV in English and a short cover letter to [email / application link] by [date].

We will contact shortlisted candidates only. All applications are treated as confidential. Your personal data will be processed under GDPR and only for recruitment purposes.