Director/a Técnico Farmacéutico// Qualified Person MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. General objective of the position is to ensure that activities related to the quality of the product comply with GMP regulations, corporate policies and established regulatory requirements. Main Responsibilities: Making critical decisions for bulk, intermediate and finished veterinary medicinal products Ensure that each batch of veterinary medicinal product has been manufactured and controlled in accordance to GMP and other applicable drug legislation, and in particular under the basis of the documentation Review and approval of PQR reports related to products within area of oversight Work in close collaboration with partners in operations, process engineering and planning to review and evaluate complaints and deviations related to the products within area of oversight Approval, tracking, assessment, completion and extension of CAPAs Support change management related to product manufacturing Review and approval of validation and qualification documentation Create, review and approve SOPs, specifications and test methods, manufacturing and packaging protocols Support the execution of site and quality related projects, as well as other continuous improvement opportunities Responsible for Quality Assurance oversight of a key quality activities Qualifications: Minimum BS degree in pharmacy, or other degree that has attained qualified person certification within Spain Minimum 5 years in the pharmaceutical industry Majority of experience supporting pharmaceutical manufacturing operations. Mix of operations and quality experience preferred At least 5 years team management experience, with proven track record of people development Qualified Person Preferable – Already has attained qualified person certification within Spain Minimal – Has the necessary background experience defined by Spanish Health Authorities to attain qualified person certification Skills: Proven track record of working cross-functionally with other departments and functions to successfully deliver high impact projects and objectives for their organization Demonstrated experience with inspections and regulatory authorities Experience with managing contract manufacturers or external partners Advanced knowledge in GMP and applicable Pharmacopoeias. Advanced knowledge of Quality System tools (change controls, deviations management, out of specifications, equipment qualification, process validation, product validation, elaboration of risk analysis, annual product reviews, claims, audits, etc.). Advanced knowledge in the processes of product manufacturing, equipment and facilities. Experience in the manufacture of biological and sterile products will be valued. Knowledge of quality control test. Fluent in Spanish Minimally required to be Business Proficient in English, preference is fluency Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.