Your Role
As the owner of a site-wide Qualification and Calibration (Q&C;) program in a GMP-regulated biopharmaceutical manufacturing environment, you will shape the strategic direction and operational performance of a function central to product quality and regulatory compliance. You will lead a team of specialists and supervisors, own both the Qualification Master Plan and the Calibration Master Plan, and serve as the primary subject matter expert during regulatory inspections. As an active member of the Engineering and Maintenance leadership team, you will drive continuous improvement through data‑driven approaches and digital tools, manage external service providers, and champion a culture of accountability and operational excellence across the manufacturing site.
Who You Are
- You bring a minimum of 8 years of experience in a GMP-regulated pharmaceutical, biopharmaceutical, or medical device manufacturing environment, including at least 5 years of direct ownership of qualification and/or calibration programs, and at least 3 years leading teams that include supervisors or team leads.
- You hold a degree or equivalent experience in Engineering (Chemical, Mechanical, Electrical, or Biomedical), Life Sciences, Pharmaceutical Sciences, or a closely related field; a postgraduate qualification in Engineering, Quality Management, or Pharmaceutical Sciences is an advantage.
- You have deep expertise in GMP qualification methodologies—including IQ/OQ/PQ and computerized system validation—alongside solid knowledge of calibration science, metrology, and risk‑based approaches such as ICH Q9 and ASTM E2500.
- You are fluent in both Spanish and English (written and spoken) — this is a mandatory requirement for the role.
- You have demonstrated experience representing a Q&C; function during regulatory inspections by authorities such as the FDA or EMA, and are well‑versed in EU GMP frameworks including Annex 11 and Annex 15, as well as data integrity principles (ALCOA+).
- You are proficient in SAP Plant Maintenance (SAP PM) and have hands‑on experience with calibration management systems and electronic qualification tools; familiarity with Lean, Six Sigma, or Operational Excellence methodologies is a plus.
- You bring a track record of managing budgets and external service provider relationships, and you lead with a coaching mindset that fosters accountability, psychological safety, and continuous improvement within your team.
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