Senior Manager GMP QA

Senior Manager GMP QA

Santhera Pharmaceuticals

Pratteln, Switzerland

Scope of Work

We are looking for a Senior Manager GMP QA to maintain and enhance Santhera’s GMP compliance and Quality Assurance strategies. Reporting to the Head of Quality Management, this role oversees GMP/GDP quality projects for development and commercial-stage products. The position collaborates with internal teams, including Technical Development & Operations (TDO), Supply Chain, and Regulatory Affairs, as well as external partners, contractors, and Health Authorities.

This role ensures products (DS and DP) meet global GMP/GDP standards, internal policies, and regulatory requirements. The job holder will be responsible for maintaining the GMP/GDP Quality Management System (QMS), conducting audits, managing compliance activities, and supporting regulatory inspections.

Key Responsibilities

• Maintain and improve GMP/GDP QMS in compliance with company policies and global regulations;
• Ensure manufacturing, testing, and distribution meet cGMP requirements;
• Conduct and oversee internal and external GMP/GDP audits;
• Manage GMP/GDP SOPs and ensure regulatory alignment;
• Oversee batch record review and product release;
• Monitor and manage supplier qualifications, audits, and performance evaluations;
• Support investigations, deviations, change controls, and CAPA implementation;
• Ensure regulatory compliance by tracking industry updates and implementing necessary changes;
• Maintain the Site Master File and ensure readiness for Health Authority inspections;
• Support Quality Council meetings, KPIs monitoring, and product defect assessments.

Required Qualifications & Experience

• Bachelor’s or advanced degree in pharmacy, chemistry, engineering, or life sciences;
• 7+ years of experience in the pharmaceutical/biotech industry;
• 5+ years in GMP Quality Assurance at a local or global level;
• Strong knowledge of cGMP global regulatory requirements and quality systems;
• Fluency in English (additional languages are a plus).

Required Competencies & Skills

• Strong problem-solving and analytical skills;
• Excellent planning, organizing, and time management abilities;
• Ability to work independently and manage multiple projects in a fast-paced environment;
• Reliable team player with leadership skills in cross-functional settings;
• Solution-oriented, proactive, and adaptable in dynamic situations.

For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required

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