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Our client is looking for a strategic QA Specialist to oversee and elevate the quality standards of their external manufacturing network. In this role, you will be the primary Quality point of contact for Contract Manufacturing Organizations (CMOs), ensuring that every drug product is manufactured, tested, and released in total alignment with GMP, GDP, and ICH guidelines. Your work will directly impact the safety and compliance of medicinal products throughout their entire lifecycle.
Key Responsibilities
* Product Stewardship: Act as the Quality Lead for assigned molecules and finished dosage forms (FDFs), overseeing lifecycle changes, API source updates, and manufacturing process optimizations at external sites.
* Quality Systems Oversight: Manage and track core QMS processes, including Deviations, Corrective and Preventive Actions (CAPAs), Out of Specification (OOS) investigations, and Change Control management.
* Technical Documentation: Author, evaluate, and approve critical documents such as Master Batch Records (MBR), Quality Agreements, SOPs, Analytical Methods, and Regulatory Filing dossiers.
* Validation & Qualification: Lead or review validation strategies (process, cleaning, and transport) and the qualification of facilities, utilities, and equipment.
* Audits & Compliance: Conduct external audits of suppliers and CMOs. Represent the quality department during Health Authority inspections and third-party audits.
* Performance Monitoring: Drive the preparation of Product Quality Reviews (PQR) and implement continuous improvement initiatives based on CMO performance data.
* Technical Support: Provide expert quality guidance for marketed products and lead GMP training sessions for internal teams and partners.
Requirements
* Academic Background: University degree in Life Sciences (Pharmacy, Chemistry, Biology) or Engineering. A Master's degree in the Pharmaceutical Industry is highly preferred.
* Professional Experience: At least 2–5 years of progressive experience within a Quality Assurance department in the pharma sector.
* Regulatory Expertise: Strong command of GMP/GDP regulations and Quality Management Systems.
* Technical Tools: Proficiency in SAP, LIMS, and Microsoft Office Suite.
* Soft Skills: Exceptional analytical mindset, ability to work under pressure, and a proactive attitude toward change and project management.
* Languages: Full professional proficiency in both English and Spanish.
* Availability: Willingness to travel occasionally for audits and professional development.