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Head of Quality (m/f/d) - Job Opportunity at Corden Pharma GmbH

Muttenz, Switzerland

Full-time

Executive

Posted: July 29, 2025

On-site

CHF 180,000 - 220,000 annually. This executive-level position in Switzerland's high-cost pharmaceutical corridor commands premium compensation due to the specialized nature of peptide manufacturing, the greenfield project complexity, and the requirement for extensive regulatory expertise across multiple jurisdictions. The Basel region's competitive pharmaceutical talent market further supports this upper-tier compensation range.

Benefits

Dynamic and exciting work environment providing exposure to cutting-edge pharmaceutical manufacturing technologies

High-responsibility position offering significant autonomy and strategic decision-making authority

Flexible working hours enabling better work-life balance and accommodation of personal scheduling needs

Positive work climate with open leadership culture fostering innovation and continuous process improvement

Strategic leadership opportunity in one of Europe's most significant CDMO expansion projects

Greenfield project experience allowing complete organizational design and implementation from inception

International work environment providing global pharmaceutical industry exposure and networking opportunities

Key Responsibilities

Develop and implement comprehensive Quality department strategy while providing strategic direction to project teams during construction and commissioning phases of a state-of-the-art peptide manufacturing facility

Execute critical project deliverables review and provide quality oversight to external engineering, commissioning and qualification companies, including validation strategy development and protocol approval

Ensure complete site compliance with multiple international regulatory requirements including Swissmedic, EMA, US-FDA, and other global health authorities

Build, hire, lead and manage high-performing Quality Assurance and Quality Control teams from ground up at the new manufacturing site

Own and continuously improve the site's comprehensive Quality Management System including document control, change control, deviation management, CAPA, training, risk management, audit, qualification and validation processes

Coordinate strategically with business development and project management teams to support seamless new project introduction and client onboarding

Provide critical quality input for technology transfers and validation activities ensuring regulatory compliance and operational excellence

Ensure all manufacturing activities comply with GMP, Corporate standards and Health and Safety policies while maintaining operational efficiency

Oversee product release processes ensuring timely and compliant quality control testing and batch disposition for customer deliverables

Manage strategic customer relationships through audit hosting, expectation management, and Quality Agreement review and approval

Act as primary regulatory liaison with local and international agencies for inspections, license upgrades and site modifications

Drive organizational culture transformation focused on quality excellence, regulatory compliance, and continuous improvement across all site operations

Participate as key member of local Leadership Team in cross-functional strategy development and execution

Develop and manage departmental budgets and resource planning to support sustainable growth objectives

Requirements

Education

University degree (BSc/MSc) in Chemistry, Pharmacy, Chemical Engineering or related field

Experience

10+ years of experience in GMP pharmaceutical manufacturing, including at least 5 years in a senior Quality leadership role

Required Skills

Solid understanding of cGMP and regulatory standards for API production Proven ability to lead inspections and audits with international customers and health authorities Strong leadership and interpersonal skills, with a collaborative mindset Experience with electronic quality systems (e.g., TrackWise, LIMS, SAP) preferred Familiarity with Lean, Six Sigma, or Operational Excellence tools is a plus Fluent in German and English; other European languages are an asset

Sauge AI Market Intelligence

Industry Trends

The pharmaceutical CDMO sector is experiencing unprecedented growth driven by increased outsourcing by big pharma companies seeking to reduce capital expenditure and focus on core R&D activities. Peptide manufacturing specifically represents one of the fastest-growing segments due to the therapeutic revolution in biologics and personalized medicine, with market projections showing continued double-digit growth through 2030. Regulatory compliance requirements are becoming increasingly stringent across global markets, with health authorities implementing more frequent inspections and higher standards for API manufacturing facilities. This trend is driving demand for experienced quality leaders who can navigate complex multi-jurisdictional regulatory environments and ensure seamless compliance across different international standards. The shift toward continuous manufacturing and Industry 4.0 technologies in pharmaceutical production is creating new quality assurance challenges and opportunities. Quality leaders must now integrate traditional GMP knowledge with advanced data analytics, electronic systems, and automated quality control processes to maintain competitive advantage in the modern CDMO landscape.

Role Significance

The role involves building and managing a comprehensive quality organization of approximately 20-35 professionals across Quality Assurance and Quality Control functions. This includes hiring and developing QA managers, validation specialists, quality control analysts, compliance officers, and documentation specialists to support full-scale API manufacturing operations.

This is a C-suite adjacent executive role with full P&L responsibility for the quality function and direct reporting to senior leadership. The position carries significant strategic weight as the quality leader will fundamentally shape the operational foundation of a multi-million dollar manufacturing facility and directly impact the company's ability to serve major pharmaceutical clients and maintain regulatory standing across global markets.

Key Projects

Complete greenfield facility startup and commissioning including validation master plan execution and regulatory readiness preparation Implementation of comprehensive Quality Management System architecture including electronic systems integration and process automation Multi-jurisdictional regulatory approval processes and pre-approval inspections with Swissmedic, EMA, and FDA authorities Strategic client onboarding and technology transfer projects for major pharmaceutical partners Continuous improvement initiatives focused on operational excellence and cost optimization while maintaining regulatory compliance

Success Factors

Deep expertise in peptide manufacturing quality requirements and the unique challenges associated with API production in this specialized therapeutic area, including understanding of complex synthesis processes and analytical method development Proven track record in greenfield pharmaceutical facility startups with demonstrated ability to build quality organizations from inception while managing construction, commissioning, and regulatory approval timelines simultaneously Strong regulatory relationship management capabilities with direct experience leading successful inspections by major health authorities and the ability to serve as primary regulatory interface for complex compliance issues Executive leadership skills with experience managing large cross-functional teams, significant budgets, and the ability to influence organizational culture while driving operational excellence in a fast-paced growth environment Strategic business acumen to align quality operations with commercial objectives while maintaining uncompromising compliance standards and supporting the company's position as a preferred CDMO partner for major pharmaceutical clients

Market Demand

Exceptionally high demand. The combination of CDMO industry expansion, peptide manufacturing specialization, and regulatory expertise requirements creates a highly competitive talent market. The greenfield nature of this opportunity and CordenPharma's strategic expansion make this a particularly sought-after executive position with limited qualified candidates available globally.

Important Skills

Critical Skills

Comprehensive GMP expertise is absolutely essential as this role requires deep understanding of pharmaceutical manufacturing regulations across multiple jurisdictions and the ability to ensure compliance during facility startup and ongoing operations. The quality leader must navigate complex regulatory requirements while maintaining operational efficiency and client satisfaction. Executive leadership capabilities are crucial for success in building and managing large teams, influencing organizational culture, and serving as a key member of the site leadership team. The ability to inspire and develop talent while driving performance in a fast-paced startup environment will directly determine the facility's success. Regulatory inspection and audit management skills are critical given the multi-jurisdictional nature of pharmaceutical manufacturing and the need to maintain approval status with various health authorities. Success requires proven ability to lead complex inspections and maintain positive regulatory relationships. Project management and change management expertise are essential for managing the complex transition from construction through commissioning to full operational status while coordinating multiple stakeholders and maintaining aggressive timelines for commercial launch.

Beneficial Skills

Advanced data analytics and Industry 4.0 knowledge will provide competitive advantage as the pharmaceutical industry increasingly adopts digital technologies for quality assurance and manufacturing optimization Lean Six Sigma and operational excellence methodologies will enable continuous improvement initiatives and cost optimization while maintaining quality standards in an increasingly competitive CDMO market Multiple language capabilities beyond German and English will facilitate broader European client relationships and regulatory interactions, supporting the facility's growth and market expansion objectives Previous CDMO or contract manufacturing experience will provide valuable insights into client relationship management, technology transfer processes, and the unique challenges of serving multiple pharmaceutical partners simultaneously

Unique Aspects

Rare opportunity to lead a complete greenfield pharmaceutical facility startup with full autonomy to design and implement quality systems, organizational structure, and operational processes from inception

Strategic involvement in CordenPharma's major expansion into peptide manufacturing, a high-growth therapeutic area with significant market potential and technical complexity

Multi-jurisdictional regulatory responsibility requiring expertise across Swiss, European, and US regulatory frameworks and the opportunity to establish relationships with multiple health authorities

Leadership role in one of Europe's most significant CDMO expansion projects with substantial capital investment and strategic importance to the company's long-term growth objectives

Opportunity to work with cutting-edge peptide manufacturing technologies and advanced quality systems in a state-of-the-art facility designed to meet future industry requirements

Career Growth

Typical progression to next-level executive roles occurs within 3-5 years given the strategic nature of this position and the valuable experience gained from successfully launching a greenfield pharmaceutical facility. The specialized peptide manufacturing expertise and multi-jurisdictional regulatory experience will create accelerated career opportunities in the rapidly growing biologics and specialty pharmaceutical sectors.

Potential Next Roles

Chief Quality Officer for multi-site pharmaceutical operations with expanded regional or global responsibility Vice President of Operations overseeing integrated quality, manufacturing, and supply chain functions General Manager or Site Director roles with full P&L responsibility for pharmaceutical manufacturing facilities Regulatory Affairs leadership positions at major pharmaceutical companies or consulting firms Executive roles at pharmaceutical regulatory agencies or industry associations

Company Overview

Corden Pharma GmbH

CordenPharma operates as a leading global Contract Development and Manufacturing Organization with approximately 3,000 employees across Europe and the United States. The company provides comprehensive pharmaceutical development and manufacturing services across six specialized technology platforms, positioning itself as a full-service partner for pharmaceutical companies seeking to outsource complex manufacturing operations while maintaining the highest quality and regulatory standards.

CordenPharma holds a strong competitive position in the global CDMO market, particularly in specialized areas such as peptides, oncology compounds, and highly potent APIs. The company's investment in expanding its peptide manufacturing capabilities through the Muttenz facility demonstrates strategic positioning to capitalize on the growing biologics market and strengthens its competitive advantage in high-value therapeutic areas.

The Muttenz location near Basel positions CordenPharma at the heart of Europe's pharmaceutical industry cluster, providing strategic access to major pharmaceutical clients, regulatory agencies, and specialized talent pools. This Swiss location offers significant advantages for serving European and global markets while maintaining the highest manufacturing and quality standards expected by international pharmaceutical partners.

CordenPharma emphasizes a collaborative, science-driven culture focused on excellence and patient impact. The company's 'People Vision' of striving for excellence while sharing passion and making a difference in patients' lives indicates a mission-driven organization that values both technical expertise and collaborative leadership approaches in achieving operational and commercial success.

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Head of Quality (m/f/d) - Job Opportunity at Corden Pharma GmbH

Benefits

Key Responsibilities

Requirements

Education

Experience

Required Skills

Sauge AI Market Intelligence

Industry Trends

Role Significance

Key Projects

Success Factors

Market Demand

Important Skills

Critical Skills

Beneficial Skills

Unique Aspects

Career Growth

Potential Next Roles

Company Overview

Corden Pharma GmbH

Data Sources & Analysis Information

Job Listings Data

Sauge AI Market Intelligence