Jobs at Pharmathen S.A.

Leads HR excellence by translating business strategy into recruitment, talent, performance, learning, workforce planning, and organizational effectiveness programs. Oversees HR systems, policies, dashboards, analytics, change management, employer branding, career paths, onboarding, talent forums, and operational KPIs. Partners with business leaders and Talent Acquisition, ensures legal and organizational compliance, and manages HR staff in a complex environment.

Manage external manufacturing procurement across CMO and CDMO partners, including sourcing, supplier selection, contract negotiation, tech transfer, launch support, cost management, and partnership governance. The role requires pharmaceutical manufacturing knowledge, GMP familiarity, commercial acumen, cross-functional leadership, and strong supplier relationship management to ensure supply continuity, compliant operations, competitive costs, and timely product launches.

Conduct safety risk assessments and genotoxicity evaluations for drugs and chemicals, coordinate with regulatory authorities, prepare toxicological responses, and compile non-clinical and clinical dossier overviews. The role requires toxicology expertise, experience with in-vitro and animal toxicity studies, analytical and clinical chemistry knowledge, regulatory guideline knowledge, strong English communication, and effective prioritization and time management.

Develops, implements, and continuously improves the pharmaceutical Quality Management System in compliance with EU GMP, ISO standards, and regulatory requirements. Manages document control, audits, inspections, deviations, CAPA, change controls, QMS KPIs, training, quality risk management, and data integrity. Collaborates with Production, QC, Regulatory Affairs, and other departments to maintain compliance and drive continuous improvement.

Ensures pharmaceutical equipment, facilities, utilities, warehouses, and production areas comply with EU cGMPs and ISO requirements. Leads validation, qualification, calibration, change control, deviation, risk management, SOP, and controlled-layout activities. Coordinates internal teams, subcontractors, customers, and site projects; evaluates validation findings; trains personnel; monitors environmental conditions and maintenance; and supports technical troubleshooting across the site and external warehouses.

Perform routine and non-routine microbiological tests on in-process, finished and environmental samples; maintain accurate test records and sample logs; investigate OOS results; support supplier and contract lab audits.

Perform routine and non-routine microbiological testing of in-process and finished products, raw materials, and environmental monitoring samples; conduct sterility testing; document results and maintain sample logs; investigate OOS results; participate in peer-review of analytical data and support supplier/contract lab audits.

Provide legal counsel across corporate and regulatory matters for the pharmaceutical company: draft, review, and negotiate contracts; ensure compliance with laws and industry regulations; represent or coordinate external counsel in proceedings; perform legal research and risk assessments; develop policies; and advise and train business stakeholders.

Support pre- and post-approval CMC regulatory activities: compile and review CTD Modules 2–5, prepare variation packages and renewals, respond to deficiency letters, liaise with authorities, suppliers and internal stakeholders, and contribute to product development and lifecycle regulatory strategy.

Lead and oversee product quality lifecycle activities to ensure cGMP compliance and product release. Manage inspections, testing, investigations (OOS/OOT), validations, CAPAs, deviations, audits, documentation, stability and APQR oversight, training, and cross-functional quality integration to continuously improve product quality.

Manages quality-related customer requests, queries, issues, and pending activities. Serves as the liaison between Pharmathen and key customers, participates in QA meetings, and develops and maintains Quality and Technical Agreements. Supports agreement interpretation, quality input for commercial and supply contracts, controlled-document authorship, internal agreement databases, cross-functional issue resolution, and KPI reporting.

Coordinates pharmaceutical customer complaint handling, investigations, documentation, stakeholder communication, sample management, supplier complaints, KPI and reconciliation reporting, audits, pharmacovigilance activities, and product recalls, including mock recall exercises. Contributes to controlled quality documentation and ensures complaint processes meet quality management requirements and deadlines.

Design, implement, and maintain enterprise security architecture and controls; monitor SIEM alerts and manage endpoint, network, and identity security. Perform vulnerability assessments, support audits and regulatory compliance (GxP, FDA, GDPR), tune DLP, assist network segmentation and cloud (Azure) security, and run BCP/DRP tests and security awareness training.

Lead complaint investigations and root-cause analysis for LAI and OSD products; collaborate with manufacturing, QC, regulatory and cross-functional teams; support audits, process and cleaning validation, OOS/OOT and statistical evaluations; author and review SOPs/TDRs and Master Records; train staff on GMP procedures; monitor KPIs, CAPAs, APQR, stability programs, data integrity, and participate in customer and authority inspections.

Support and maintain the site Quality Management System: author/review controlled documents, run audits/inspections, train staff, ensure ISO 9001 and EU cGMP compliance, manage document/training/audit/CAPA systems, participate in investigations, and support validations, stability, monitoring, and data integrity activities.

Ensure cGMP and ISO 9001 compliance for external suppliers and service providers. Manage supplier qualification, audits, notifications, CAPA follow-up, risk assessments (including excipients), KPI monitoring, and supplier quality agreements. Support change control, deviations, SOPs, inspections, and customer/regulatory audits.

Ensure external supply quality and compliance with cGMP and ISO 9001. Manage supplier qualification, audits, complaints, notifications, CAPA follow-up, and excipient risk assessments per EU guideline. Maintain audit plans, quality agreements, KPIs, and controlled quality documentation. Support change control, deviations, risk management, customer audits, and regulatory inspections.

Conduct analytical testing across product lifecycle in a GLP environment, develop and validate methods (HPLC, GC, UV, IR), analyze and interpret data, support stability and registration studies, maintain lab systems and GMP compliance, and prepare technical documentation.

Ensure calibration, qualification and validation of equipment, warehouses and production areas; prepare and control SOPs/TDRs and controlled layouts; monitor environmental conditions and maintenance; manage change controls, deviations, risk assessments; train staff on validation/qualification controls and ensure compliance with ISO 9001:2015 and EU cGMPs.

Pharmathen invites candidates to submit their resumes for future career opportunities. They emphasize the confidentiality of applications and compliance with GDPR.