Site Quality Director (Pharmaceutical Quality)

Location: Fully onsite in Xochimilco, Mexico. Relocation support is not provided; candidates must be willing to work from the specified location.

Company

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

What you will do

• Lead quality assurance policies and procedures to ensure compliance with hirify.global policies and global industry standards.
• Ensure product quality, efficacy, safety, and compliance with market requirements, including FDA guidelines and quality agreements for outsourced products and services.
• Build a culture of continuous improvement across quality processes, systems, and methods.
• Manage internal audits, inspections, and regulatory readiness for the site.
• Lead, train, and develop the quality organization while managing its budget and financial resources.
• Act as the Responsible Health Officer before COFEPRIS and oversee the effectiveness of quality systems and data management.

Requirements

• University degree in Pharmacy, Chemistry, or a related field.
• 10+ years of quality management experience in the pharmaceutical industry.
• 5+ years of experience leading a team of at least five direct reports.
• 3+ years of experience in executive roles at Senior Manager or Director level.
• Strong knowledge of pharmaceutical regulations, NOM-059-SSA1, SHE, GMP, GxP, quality assurance, manufacturing, and supply chain requirements.
• Fluency in Spanish and English, both oral and written, is required.

Nice to have

• Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, Public Health, Quality Assurance, or a related field.
• Strong leadership, problem-solving, decision-making, communication, and interpersonal skills.

Culture & Benefits

• Direct contract with superior benefits.
• Work-life balance initiatives and workplace perks.
• Learning and development opportunities.
• Inclusive equal opportunity workplace.