Senior Quality Governance & Policy Architect

Inova Consulting; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Inova is seeking a senior QA Governance & Policy Writer to support a pharmaceutical client in the Basel area with establishing a new Quality Management System. You will define governance, translate the framework into day-to-day documentation, and work closely with Quality leadership to ensure clear, compliant practices.

You will develop Quality Policies, Master Documents, governance documents, SOPs, and other QMS documentation, collaborating with cross-functional teams to prepare for regulatory

Qualifikationen

• Minimum 10 years of experience in Pharmaceutical Quality Assurance.
• Strong experience in Quality Governance, QMS implementation, and transformation.
• Proven ability to author Quality Policies, Master Documents, SOPs, and controlled documentation.
• Excellent knowledge of GMP requirements and Quality Management Systems.
• Senior, autonomous, delivery-focused with strong stakeholder management.
• Fluent English; no additional language required.

Aufgaben

• Define, structure, and strengthen the Quality Governance framework within a new QMS.
• Establish governance principles, accountabilities, decision-making, and escalation.
• Develop and author Quality Policies, Master Documents, SOPs, and other QMS docs.
• Define and maintain a clear hierarchy across Quality documentation levels.
• Translate regulatory and GMP requirements into pragmatic procedures.
• Support the implementation, deployment, and maturation of the new QMS.
• Collaborate with Quality, Manufacturing, Engineering, and Supply Chain teams.

Kenntnisse

Quality governance

QMS implementation

Documentation writing

Stakeholder management

Jobbeschreibung

Inova is seeking a senior QA Governance & Policy Writer to support a pharmaceutical client in the Basel area with establishing a new Quality Management System. You will define governance, translate the framework into day-to-day documentation, and work closely with Quality leadership to ensure clear, compliant practices.

You will develop Quality Policies, Master Documents, governance documents, SOPs, and other QMS documentation, collaborating with cross-functional teams to prepare for regulatory