Quality Manager

Description

Job Summary: We are seeking a Quality Manager to lead the quality management system in a biotechnology company, ensuring regulatory compliance across all areas. Key Highlights: 1. Leads the quality management system and ensures regulatory compliance. 2. Cross-functional role with autonomy, judgment, and rigor in a regulatory environment. 3. Contributes to building a leading biotechnology company in Europe. **About Ovum SPF** We are a biotechnology company specializing in the production of Specific Pathogen Free (SPF) eggs as an essential substrate for vaccine manufacturing. We operate under the most stringent standards of the international pharmaceutical industry, following the European Pharmacopoeia 5\.2\.2 and USDA Memorandum 800\.65\. We are currently in a phase of consolidation and growth and seek technical professionals eager to contribute to building a reference company in Europe. **The Role** We are seeking a Quality Manager to lead the plant’s quality management system and ensure regulatory compliance across all operational areas. This is a cross-functional role: the individual serves as an independent control body, verifying that processes, results, and documentation consistently meet applicable standards. The role requires autonomy, sound judgment, and the ability to maintain rigor in a highly regulated environment. **Responsibilities** *Quality System* * Design, implementation, and maintenance of a quality management system (QMS) tailored to pharmaceutical and biotechnology industry requirements * Drafting, review, and control of SOPs, records, and technical instructions * Management of non-conformances, corrective and preventive actions (CAPA) * Supervision and coordination of internal and external audits *Verification and Traceability* * Verification of compliance with quality standards at all stages of the production process, without responsibility for technical execution of those processes * Review of batch documentation and issuance of quality certificates * Oversight of end-to-end traceability from production to delivery * Monitoring of quality indicators and detection of deviations *Customer and Regulatory Authority Interaction* * Acting as liaison during pharmaceutical customer audits, conducting or receiving audits fully in English when required * Preparing technical responses to quality questionnaires (e.g., Quality Agreements, supplier questionnaires) * Monitoring relevant regulatory changes and adapting procedures accordingly **Requirements** * Minimum 3 years’ experience in QA roles within pharmaceutical, biotechnology, or biological production environments characterized by high regulatory stringency * Solid knowledge of GMP or equivalent regulations applicable to biological production * Advanced English proficiency, capable of conducting or receiving audits entirely in English * Ability to produce precise technical documentation and competent use of document management systems * University degree in life sciences or engineering; quality experience will be prioritized over specific academic discipline **Preferred Qualifications** * Experience in pharmaceutical industry customer audits or in managing Quality Agreements * Knowledge of the regulatory framework concerning biological substrates or animal-derived products for animal and/or human health. **Terms & Conditions** * Permanent contract * Technically and regulatorily prominent position within the organization * Opportunity to join a growing biotechnology project with international clients Salary: €35,000.00–€45,000.00 per year Application Questions: * Are you available to work on-site in Cascante (Navarra)? * Do you have experience working within a quality system under GMP or equivalent regulations in a pharmaceutical or biotechnology environment? * Do you hold a valid driver’s license and have access to a personal vehicle? Language: * Advanced English, both spoken and written (Mandatory) Work Location: On-site employment