Quality Lead (Ampoules)

Gerresheimer; Santiago de Querétaro; Presencial; MXN 719,000 - 1,079,000; Jornada completa

Descripción de la vacante

A leading pharmaceutical packaging company in Querétaro is seeking a Quality Manager to ensure effective implementation of quality processes and compliance with regulatory standards. The role involves managing quality control resources, leading audits, and driving quality performance across manufacturing areas. Candidates should have a Bachelor’s degree and 3-6 years of experience in quality management within manufacturing environments. Strong knowledge of ISO standards and proficient in Lean Manufacturing are essential for success.

Formación

• 3 – 6 years of experience in quality processes within manufacturing environments.
• Strong knowledge of regulatory standards and ISO certifications.
• Experience leading quality teams in a manufacturing setting.

Responsabilidades

• Ensure product compliance with customer and regulatory quality requirements.
• Lead and manage the Integrated Management System.
• Monitor KPIs and implement corrective actions.

Conocimientos

Quality Management Systems

Lean Manufacturing

Quality problem-solving tools

Advanced English proficiency

Educación

Bachelor’s degree in Quality, Engineering, or related field

Herramientas

SAP

Minitab

Descripción del empleo

Gerresheimer Querétaro S.A. in Mexico produces primary glass packaging for pharmaceutical use. Type I glass is produced in clear and amber glass. The broad product range includes ampoules, serum vials, screw thread vials, ready-to-fill syringes and cartridges.

Job Description

Ensuring the effective implementation and continuous improvement of the Integrated Management System, in compliance with applicable regulations and customer requirements. Direct support to manufacturing areas by managing quality control resources and ensuring process reliability and product quality.

Key leadership role in driving quality performance, supporting audits, managing KPIs, and strengthening GMP/GDP compliance. The manager leads quality teams in inspection and process control, ensuring alignment with business objectives and regulatory standards in a highly regulated manufacturing environment.

Key Responsibilities

• Ensure product compliance with customer, regulatory, and internal quality requirements.
• Lead and strengthen the Integrated Management System and quality culture.
• Manage Quality Control resources, inspection systems, and analytical methods.
• Monitor KPIs and implement corrective actions for non-conforming results.
• Support internal, customer, and regulatory audits and follow up on action plans.
• Ensure qualification and continuous training of quality inspection personnel.
• Lead continuous improvement initiatives focused on quality, cost, and efficiency.
• Ensure compliance with GMP, GDP, and safety policies across assigned areas.

Qualifications

• Bachelor’s degree completed; specialization in Quality, Engineering, or related field preferred.
• 3 – 6 years of experience in quality processes within manufacturing environments.
• Strong knowledge of Quality Management Systems and regulatory standards.
• Experience with ISO standards (ISO 9001, ISO 13485, ISO 15378, ISO 14001, ISO 45001).
• Proficiency in Lean Manufacturing, Core Tools (FMEA, Control Plans), and Six Sigma.
• Experience with quality problem-solving tools (DMAIC, 8D, 5 Why, Ishikawa).
• Knowledge of AQL, ANSI tables, SAP, and Minitab.
• Advanced English proficiency (business and technical communication).