Head of Quality Assurance

Discover International; Baden-Württemberg; Vor Ort; EUR 140.000 - 200.000; Vollzeit

Zusammenfassung

Discover International seeks an experienced Head of Quality to lead and develop the Quality function within a growing pharmaceutical/biotech organisation. This is a senior leadership role with responsibility for ensuring a strong quality culture, regulatory compliance, and driving continuous improvement across the business.

The successful candidate will provide strategic direction across Quality Assurance and Quality Systems, collaborating with senior leadership and cross-functional teams to

Qualifikationen

• Senior Quality leadership experience in pharma/biotech.
• Strong knowledge of GxP regulations and Quality Management Systems.
• Proven experience leading audits, inspections, CAPAs and quality risk management.
• Ability to lead and develop teams while influencing senior stakeholders.
• Strategic, commercially aware with executive-level presence.

Aufgaben

• Lead and develop the Quality strategy and QMS.
• Provide leadership across QA, QC and related functions.
• Ensure GMP, GCP, GDP and other GxP compliance.
• Oversee deviations, CAPAs, change controls, investigations and risk management.
• Lead internal, supplier and regulatory audit readiness.
• Act as senior Quality representative with regulators and partners.
• Partner with Manufacturing, R&D, Clinical, Regulatory to embed quality culture.
• Identify opportunities for continuous improvement and quality transformation.
• Provide Quality input to strategic decisions and new product development.
• Coach and develop the Quality team to high performance.

Kenntnisse

Quality leadership

GxP compliance

Audit and inspection readiness

CAPA management

Stakeholder management

Jobbeschreibung

We are seeking an experienced Head of Quality to lead and develop the Quality function within a growing pharmaceutical/biotech organisation. This is a senior leadership position with responsibility for ensuring a strong quality culture, maintaining regulatory compliance, and driving continuous improvement across the business.

The successful candidate will provide strategic direction across Quality Assurance and Quality Systems, working closely with senior leadership and cross-functional teams to ensure products, processes and operations meet applicable GxP, regulatory and company standards.

Key Responsibilities:

• Lead and develop the overall Quality strategy and Quality Management System (QMS).
• Provide leadership across QA, QC and/or relevant Quality functions.
• Ensure compliance with applicable GMP, GCP, GDP and other GxP requirements.
• Oversee deviations, CAPAs, change controls, investigations and quality risk management.
• Lead internal, supplier and regulatory audit and inspection readiness activities.
• Act as a senior Quality representative with regulatory authorities, partners and external stakeholders.
• Partner with Manufacturing, R&D, Clinical, Regulatory and other functions to embed a strong quality culture.
• Identify opportunities for continuous improvement and drive quality-related transformation initiatives.
• Provide Quality input into strategic business decisions, projects and new product development.
• Coach, mentor and develop the Quality team, building a high-performing organisation.

About You:

• Significant experience in a senior Quality leadership role within the pharmaceutical, biotech or life sciences industry.
• Strong knowledge of GxP regulations and Quality Management Systems.
• Proven experience leading audits, inspections, investigations, CAPAs and quality risk management.
• Strong understanding of regulatory expectations and experience operating in a regulated environment.
• Demonstrated ability to lead and develop teams while influencing senior stakeholders.
• Strategic, commercially aware and confident operating at an executive level.
• Excellent communication, stakeholder management and decision-making skills.

What the Role Offers:

This is an excellent opportunity for an established Quality leader to take ownership of the Quality function, influence organisational strategy and play a key role in shaping the company's quality culture and future growth.