Technical Director – Pharmaceutical Manufacturing

About the role

The company is a leading pharmaceutical manufacturer seeking a Technical Director to oversee technical, quality, and regulatory functions across its production sites. This senior position ensures compliance with global standards, safeguards patient safety, and drives continuous improvement.

Key responsibilities

• Act as the Technical Responsible Person before regulatory authorities.
• Ensure compliance with GMP, GLP, and all applicable pharmaceutical regulations.
• Lead Quality Assurance, Quality Control, and Technical Operations teams.
• Approve product releases and manage investigations related to deviations, CAPA, OOS/OOT, complaints, and recalls.
• Lead regulatory inspections, audits, and interactions with health authorities.
• Support regulatory submissions, technical documentation, and manufacturing compliance activities.

Required profile

• Bachelor’s degree in Pharmaceutical Chemistry.
• Post‑graduate specialization or Master’s in Quality, Manufacturing, Regulatory Affairs, Industrial Processes, or Business Administration.
• 10+ years of experience in pharmaceutical manufacturing, with proven leadership of technical affairs, QA, QC, and QMS.
• Experience interacting with agencies such as FDA, INVIMA, ANVISA, COFEPRIS, DIGEMID, or TGA.
• Fluent English (C1) and availability to travel when required.

Required skills

• GMP compliance
• GLP compliance
• Product release processes
• CAPA management
• OOS/OOT investigations
• Regulatory inspections and audits