Expert Compliance Manufacturing (Biotech)

Location: Yverdon-les-Bains, Switzerland

Company

hirify.global is a biotech company developing and manufacturing regulated pharmaceutical products.

What you will do

• Manage deviations, investigations, CAPA, risk assessments, and change control activities within required timelines.
• Maintain inspection-ready compliance systems and act as a subject matter expert during health authority inspections.
• Define manufacturing support KPIs, monitor quality and operational performance, and support continuous improvement.
• Author, review, and approve SOPs, work instructions, and manufacturing support documentation.
• Maintain the manufacturing training process and coach staff on GMP guidelines and department-specific procedures.
• Implement quality compliance initiatives and support resolution of process and equipment issues in collaboration with QA.

Requirements

• Bachelor’s, master’s, or engineering degree in pharmaceutical or biotech engineering.
• 5–7 years of relevant biotech experience in cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation.
• Direct experience with FMEA, root cause analysis, and related quality assessment tools.
• Proven leadership experience managing a team in a fast-paced, highly regulated environment.
• Fluent French and English.
• Teamwork-oriented mindset and adherence to compliance, legal requirements, and company guidelines.

Culture & Benefits

• Strong focus on business integrity, ethics, GMP, and quality compliance.
• Mentoring and coaching responsibilities within the manufacturing organization.
• Collaboration with QA, manufacturing management, and other team members on compliance and process improvement.