Pharmaceutical CDMO | Quality Organization

Role Summary

The Site Head of Quality bears full accountability for the strategic leadership and operational management of the Quality organization at the site. In this senior leadership role, the incumbent ensures full compliance with regulatory standards, drives a culture of quality and continuous improvement, and aligns site quality operations with the global quality strategy of the group. The position serves as the primary quality interface for customers, regulatory authorities, and senior management.

Key Responsibilities

Strategic Quality Leadership

Develop and implement a comprehensive site quality strategy aligned with the global quality framework and corporate objectives
Act as a senior quality leader and role model, embedding a culture of quality, accountability, and continuous improvement across all site functions
Represent the Quality organization in site leadership forums and cross-functional decision-making processes

Quality Assurance & Quality Control Management

Provide strategic oversight and day-to-day guidance to the Head QA, Head QC, and Qualified Person (QP), ensuring effective collaboration and communication across the full quality organization
Ensure appropriate staffing, development, and performance management of a quality team of approximately 100 employees
Oversee the design, implementation, and continuous improvement of the site Quality Management System (QMS)
Ensure robust oversight of deviations, CAPA, change control, complaints, and quality risk management processes

Regulatory Compliance & GMP

Ensure full compliance with Good Manufacturing Practices (GMP), applicable regulatory requirements (FDA, EMA, and other relevant authorities), and internal quality systems
Lead the preparation, management, and follow-up of regulatory authority inspections and internal/external audits
Maintain and develop positive relationships with regulatory authorities, ensuring timely and transparent communication
Serve as the primary quality contact for customers, managing customer audits and quality agreements in the CDMO context
Build and maintain trusted relationships with key customers, ensuring customer quality expectations are understood and met
Collaborate closely with Warehouse, Production, and other site functions to ensure seamless quality integration across all operations
Define, monitor, and report key quality metrics, KPIs, trends, and risk indicators to the Vice President Quality and Site Manager
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Prepare and present quality performance reviews to senior management and corporate stakeholders

Qualifications & Experience

Education

PhD or Master's degree (or equivalent) in Pharmacy, Chemistry, Biology, Biochemistry, or a related scientific discipline

Professional Experience

Minimum 10 years of progressive experience in quality management within the pharmaceutical industry, ideally in a CDMO or multi-product manufacturing environment
Minimum 5 years in a senior quality leadership role with responsibility for sizeable teams (50+ employees)
Proven track record in managing regulatory authority inspections (FDA, EMA, PMDA, or similar) and customer audits
Demonstrable experience in developing and implementing quality strategies across complex, multi-functional organizations

Technical Knowledge

Deep expertise in GMP regulations, ICH guidelines, FDA 21 CFR Parts 210/211, EU GMP Annex requirements, and other applicable regulatory standards
Strong understanding of pharmaceutical manufacturing processes, analytical methods, and QMS design
Solid knowledge of quality risk management principles (ICH Q9) and pharmaceutical quality systems (ICH Q10)

Leadership & Soft Skills

Demonstrated ability to lead, inspire, and develop large, cross-functional teams in a complex organizational environment
Strong strategic thinking combined with pragmatic execution capability
Excellent communication and stakeholder management skills at all organizational levels, including senior executives, authorities, and customers
High level of resilience, decision-making competence under pressure, and a proactive approach to risk management
Fluent in German and English (written and spoken)

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