Operations Director (San Juan Del Río)

MAIN PURPOSE OF ROLE

Provide strategic and operational leadership for a multi‑product, FDA‑regulated manufacturing organization. This role shapes production strategy, ensures compliant and efficient operations across multiple shifts and builds scalable manufacturing capabilities aligned to business objectives. Partnering cross‑functionally with R&D, Quality, Regulatory, Supply Chain, and Engineering, the role enables successful product transitions, drives continuous improvement, mitigates operational risk, and develops high‑performing teams to deliver quality, cost, and supply excellence.

MAIN RESPONSIBILITIES

• Highly experienced in Production management: oversee day‑to‑day managerial function with strategic and policy development aspects that impact medium‑term operational performance.
• Key member in the formulation of production strategy, policy and procedures.
• Develop and oversee production activities to maximize resource utilization and meet established specifications and schedules.
• Oversee manufacturing activities of multiple product lines operating on multiple shifts.
• Develop and implement short‑ and long‑term strategic plans to ensure manufacturing systems meet business objectives.
• Work cross‑functionally with R&D, Quality, Clinical, Regulatory, and other departments to ensure effective product transitions into production.
• Collaborate with Supply Chain Management to develop effective production planning and inventory systems; ensure accurate tracking and accounting of materials and WIP.
• Partner with Continuous Improvement and Engineering functions to develop effective manufacturing processes capable of meeting quality, cost, and supply chain objectives.
• Anticipate and resolve highest‑level issues and conflicts that could impact operational success.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
• Set goals aligned to department plans and manage goal execution through coaching and mentoring.
• Maintain a safe and professional work environment.
• Support all company initiatives, including QMS, EMS, and other regulatory requirements.
• Comply with U.S. Food and Drug Administration regulations, company policies, operating procedures, and task assignments.
• Maintain positive and cooperative communication with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS

• Master’s degree in industrial engineering, business administration, or engineering fields.

EXPERIENCE & BACKGROUND (+5 years)

• Manufacturing and Operations: experience leading large‑scale manual operations.
• Knowledge of Med Device products preferred; knowledge of FDA regulations and highly regulated environment a plus.
• Validations and ramp‑up production: experience in line transfers for highly regulated environments.
• Experience training large organizations and achieving ramp‑ups.
• Experience conducting self‑inspections in a GMP context based on FDA requirements, COFEPRIS, EMA requirements.
• Financial Acumen: knowledge of financial statements, planning, budgeting, forecasting; manage scrap processes and product cost glidepaths.
• Quality Processes: understanding of quality processes; manage manufacturing expectations including CAPAs and non‑conformances.
• Business Acumen: experience in a broader enterprise/cross‑division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including setting goals and providing positive, constructive feedback to build relationships and improve results.
• Ability to work effectively within a team in a fast‑paced, changing environment.
• Strong verbal and written communication to effectively interact at multiple organizational levels.
• Multi‑task, prioritize, and meet deadlines in a timely manner.
• Strong organizational, planning, and follow‑up skills and ability to hold others accountable.
• Ability to travel approximately 15%, including internationally.
• Fully bilingual (English & Spanish).