External Quality, Associate Director (Pharmaceutical)

Location: Madrid, Spain; hybrid work arrangement. Ability to travel up to 25%, occasionally on short notice.

Company

hirify.global is a global healthcare company focused on women's health, biosimilars, and other health solutions.

What you will do

• Provide quality oversight for external entities manufacturing, testing, packaging, storing, and distributing company products.
• Ensure compliance with GMP, regulatory requirements, company policies, and approved manufacturing and testing processes.
• Oversee quality control activities, product testing, batch documentation, deviation investigations, and product release activities.
• Maintain audit readiness, support regulatory inspections, oversee complaints and change controls, and review quality metrics and product quality reports.
• Analyze trends and root causes, develop process improvements, and build effective quality systems at external manufacturing sites.
• Lead and develop Quality Assurance professionals when applicable, including performance management and workload planning.

Requirements

• Degree in Science, Engineering, Pharmacy, Chemistry, Biology, Microbiology, or a related technical discipline.
• At least 5 years of relevant pharmaceutical or biotechnology industry experience.
• Thorough knowledge of Quality Systems, Quality Assurance, Quality Control, global GMP, and regulatory requirements.
• Strong interpersonal, communication, coaching, negotiation, and persuasion skills.
• Ability to work across organizational boundaries and demonstrate relationship-building and leadership skills.
• Professional English communication skills, written and verbal, are required.

Nice to have

• Previous management experience.
• Contractual and financial awareness.
• Experience leading significant investigations and fact-finding meetings affecting marketed products.
• Experience participating in regulatory inspections and working with domestic and foreign regulations and compendia.

Culture & Benefits

• Hybrid work arrangement.
• Regular travel of up to 25% may be required.
• Regular employee development and performance discussions for direct reports.
• Work in an inclusive environment as an equal opportunity employer.
• Visa sponsorship is not available.
• No relocation support is provided.