QA Governance & Policy Writer

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

Industry: Pharmaceutical / Life Sciences

About Inova

QA Governance & Policy Writer

Company: Inova (www.inova-sa.ch)

Location: Basel Area, Switzerland

Contract Type: Full-time - On-site

Start Date: ASAP

Industry: Pharmaceutical / Life Sciences

About Inova

Inova is a Swiss consulting and engineering firm supporting Life Sciences organizations with high-value expertise across Quality, Compliance, Engineering, Automation, and Digital Transformation.

We help our clients establish robust, compliant, and future-ready operating models, from Quality governance and QMS implementation to manufacturing readiness and digital transformation.

Position Overview

We are seeking a senior QA Governance & Policy Writer to support a pharmaceutical client in the Basel area with the implementation and structuring of a newly established Quality Management System.

This role goes well beyond technical writing. We are looking for an experienced Pharmaceutical Quality professional capable of defining, challenging, and strengthening the appropriate level of Quality Governance, while taking hands-on ownership of the documentation required to translate that framework into day-to-day operations.

Working closely with Quality leadership and key business functions, you will develop and structure Quality Policies, Master Documents, governance documents, SOPs, and supporting QMS documentation in preparation for regulatory inspection and the start of pharmaceutical manufacturing activities.

The ideal candidate combines strong GMP judgement, strategic Quality Governance expertise, and excellent technical writing capabilities, with the ability to move seamlessly between framework definition and practical execution.

Key Responsibilities

• Define, structure, and strengthen the overall Quality Governance framework within a newly established QMS
• Establish clear governance principles, accountabilities, decision-making processes, and escalation mechanisms
• Develop and author Quality Policies, Master Documents, governance documents, SOPs, and other QMS documentation
• Define and maintain a clear hierarchy and consistency across the different levels of Quality documentation
• Translate regulatory, GMP, and corporate Quality requirements into clear, pragmatic, and operational procedures
• Review and challenge existing Quality concepts, identifying opportunities to improve robustness, clarity, and compliance
• Support the implementation, deployment, and maturation of the new Quality Management System
• Identify documentation, governance, and procedural gaps ahead of regulatory inspection
• Ensure Quality documentation is inspection-ready and appropriate for the transition into routine pharmaceutical manufacturing
• Support Quality leadership in establishing sustainable governance practices for future operations
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, Supply Chain, and other relevant stakeholders
• Ensure documentation supports both regulatory compliance and practical execution within the organization

Profile Requirements

• Minimum 10 years of experience in Pharmaceutical Quality Assurance
• Strong experience in Quality Governance, QMS implementation, QMS transformation, or Quality System design
• Demonstrated experience authoring Quality Policies, Master Documents, governance frameworks, SOPs, and controlled Quality documentation
• Excellent knowledge of pharmaceutical GMP requirements and Quality Management Systems
• Strong understanding of document hierarchy, governance models, Quality responsibilities, and escalation principles
• Experience supporting a new pharmaceutical site, new organization, QMS build-up, production start-up, or major Quality transformation is highly valued
• Proven ability to operate at both strategic and execution levels, from defining governance principles to drafting detailed procedures
• Strong critical thinking and the ability to challenge existing approaches constructively and pragmatically
• Excellent technical, procedural, and policy writing capabilities
• Able to translate complex regulatory and Quality requirements into clear and usable documentation
• Senior, autonomous, structured, and delivery-oriented mindset
• Strong stakeholder management and communication skills
• Fluent English required; no additional language required

Why Join Inova?

• Play a central role in shaping the Quality Governance framework of a pharmaceutical organization entering a critical phase of development
• Contribute directly to QMS implementation, inspection readiness, and manufacturing launch
• Work at both strategic and operational levels, combining Quality Governance with hands-on documentation development
• Collaborate closely with senior Quality stakeholders in a fast-moving Life Sciences environment
• Join a dynamic Swiss consulting organization that values expertise, autonomy, precision, and collaboration

Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.