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QA Specialist – Audits - Job Opportunity at Sterling Pharma Solutions

Ringaskiddy, Ireland
Full-time
Mid-level
Posted: July 10, 2025
On-site
EUR 55,000 - 70,000 per year. This estimate reflects the mid-level experience requirement, specialized pharmaceutical industry focus, and Ireland's competitive life sciences salary market. The role's responsibility for regulatory compliance and audit management typically commands premium compensation in the pharmaceutical sector.

Benefits

Equal opportunities employment providing inclusive workplace culture that values diversity across all demographics
Access to comprehensive professional development through specialized audit training programs and regulatory knowledge advancement
Career progression opportunities within a rapidly expanding global CDMO organization with 50+ years of industry heritage
Exposure to cutting-edge pharmaceutical development including Active Pharmaceutical Ingredients (APIs) and Antibody Drug Conjugate (ADC) research
Collaborative work environment with cross-functional teams and subject matter experts across multiple international facilities
Professional recognition through external auditor qualification and regulatory expertise development

Key Responsibilities

Lead enterprise-wide internal audit and self-inspection programs ensuring regulatory compliance across all pharmaceutical manufacturing operations while developing and training internal auditor capabilities
Execute strategic supplier and service provider audits as qualified external auditor, directly impacting supply chain quality and risk management for critical pharmaceutical operations
Orchestrate comprehensive regulatory and customer inspection preparation activities, serving as primary liaison for health authority interactions and ensuring seamless compliance demonstration
Drive cross-functional collaboration with subject matter experts to coordinate responses to regulatory inspections, directly influencing company's regulatory standing and market access
Conduct strategic compliance gap analyses across multiple Sterling sites, identifying systemic risks and implementing enterprise-wide corrective actions
Design and deliver specialized audit training programs, building organizational capability and ensuring consistent quality standards across all operations
Manage critical customer quality documentation and Site Master File maintenance, directly supporting commercial relationships and regulatory submissions
Serve as designated supplier relations representative, managing vendor relationships that are essential to pharmaceutical manufacturing operations

Requirements

Education

Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Experience

Minimum 3 years' experience working in the pharmaceutical industry in a Quality Role or a Production Role

Required Skills

Computer literacy (e.g., MS-project, Power Point, document management systems, databases) available and ability to quickly learn new software, tracking tools and associated processes Experienced in influencing people, negotiation, and communication skills Excellent organizational skills to drive projects with a proactive and action-oriented attitude Skilled at identifying and resolving areas of concern in relation to quality Good working knowledge of GMP regulations required within the pharmaceutical industry Proven record of accomplishment of successfully working in interdisciplinary teams and of simultaneously planning, coordinating and/or leading activities on projects
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Industry Trends

The pharmaceutical contract development and manufacturing organization (CDMO) sector is experiencing unprecedented growth driven by increased outsourcing by major pharmaceutical companies seeking to reduce costs and accelerate time-to-market for new drug developments. This trend is creating significant demand for quality assurance professionals with specialized audit expertise. Regulatory compliance requirements are becoming increasingly stringent globally, with health authorities implementing more frequent and comprehensive inspections. The FDA's emphasis on quality metrics and the EU's updated GMP guidelines are driving demand for professionals who can navigate complex regulatory landscapes. The rise of personalized medicine and biologics manufacturing, including Antibody Drug Conjugates (ADCs), is creating new quality challenges that require specialized audit expertise. Companies are investing heavily in professionals who can ensure compliance in these emerging therapeutic areas. Digital transformation in pharmaceutical manufacturing is revolutionizing quality systems, with electronic batch records, real-time monitoring, and AI-driven quality analytics becoming standard. QA professionals must now combine traditional audit skills with digital literacy to remain competitive.

Role Significance

Typically manages or coordinates with 5-10 internal auditors and interfaces with 15-20 cross-functional team members including production, regulatory affairs, and supplier management teams. The role serves as a central coordination point for quality-related activities across multiple departments.
This is a mid-level specialist role with significant autonomous responsibility for critical quality systems. The position carries substantial influence over regulatory compliance and business risk management, requiring independent decision-making on complex quality matters that directly impact company operations and regulatory standing.

Key Projects

Implementation of risk-based audit programs aligned with ICH Q9 quality risk management principles Development of supplier qualification and ongoing monitoring programs for critical pharmaceutical materials Leadership of regulatory inspection readiness initiatives including mock inspections and remediation activities Cross-site compliance harmonization projects ensuring consistent quality standards across global operations

Success Factors

Deep understanding of pharmaceutical regulations including FDA, EMA, and ICH guidelines, with ability to translate regulatory requirements into practical audit procedures and training programs Strong project management capabilities with proven ability to coordinate complex multi-departmental initiatives while maintaining strict timelines and quality standards Exceptional communication and influencing skills to effectively manage relationships with regulatory authorities, customers, and internal stakeholders at all organizational levels Analytical mindset with ability to identify systemic quality issues and develop comprehensive corrective and preventive action plans Adaptability to rapidly changing regulatory landscape and emerging pharmaceutical technologies, particularly in biologics and specialty drug manufacturing

Market Demand

High demand. The pharmaceutical industry's continued expansion in Ireland, combined with increasing regulatory complexity and the specialized nature of CDMO operations, creates strong market demand for experienced QA audit professionals.

Important Skills

Critical Skills

GMP regulatory knowledge forms the foundation of all quality assurance activities in pharmaceutical manufacturing. This expertise ensures compliance with evolving regulatory requirements and enables effective communication with health authorities during inspections. Project management and organizational skills are essential for coordinating complex audit programs, managing multiple stakeholders, and ensuring timely completion of quality initiatives that directly impact business operations. Communication and influencing abilities are crucial for successfully managing relationships with regulatory authorities, training internal teams, and coordinating cross-functional responses to quality challenges. Analytical and problem-solving capabilities enable identification of systemic quality issues and development of effective corrective actions that prevent recurring problems and maintain regulatory compliance.

Beneficial Skills

Digital literacy in modern pharmaceutical manufacturing systems including electronic batch records, quality management systems, and data analytics platforms will become increasingly important as the industry undergoes digital transformation. Knowledge of emerging pharmaceutical technologies including biologics, cell and gene therapy, and personalized medicine will provide competitive advantage as the industry evolves toward more specialized therapeutic areas. Understanding of supply chain management and vendor qualification processes will enhance effectiveness in the designated supplier relations role and support strategic sourcing decisions. Familiarity with international regulatory frameworks beyond EU and US requirements will support Sterling's global expansion and enhance versatility in managing diverse customer requirements.

Unique Aspects

Exposure to both traditional API manufacturing and innovative ADC development provides rare opportunity to work with cutting-edge pharmaceutical technologies while maintaining expertise in established drug manufacturing processes
The role combines strategic audit program management with hands-on external auditing responsibilities, offering both leadership development and technical skill enhancement
Direct involvement in regulatory inspections and customer audits provides exceptional visibility into industry best practices and regulatory expectations
Cross-functional designee role for supplier relations adds commercial dimension to traditional quality responsibilities, broadening professional scope and market understanding

Career Growth

Progression to senior management roles typically occurs within 3-5 years with demonstrated success in regulatory compliance, team leadership, and strategic quality initiatives. The specialized nature of pharmaceutical quality provides clear advancement pathways.

Potential Next Roles

QA Manager with broader departmental oversight and strategic quality planning responsibilities Regulatory Affairs Manager focusing on submission strategy and health authority interactions Site Quality Director with full site quality responsibility including validation, compliance, and quality systems Corporate Quality Director overseeing quality operations across multiple manufacturing sites

Company Overview

Sterling Pharma Solutions

Sterling Pharma Solutions represents a well-established contract development and manufacturing organization with over 50 years of pharmaceutical industry experience. The company operates as a specialized CDMO focusing on Active Pharmaceutical Ingredients (APIs) and cutting-edge Antibody Drug Conjugate (ADC) development, positioning itself at the forefront of pharmaceutical innovation.

Sterling maintains a strong market position as a mid-tier CDMO with significant expertise in complex pharmaceutical manufacturing. The company's 50+ year history and 800+ employee base demonstrate stability and growth in the competitive pharmaceutical services market.
The Ringaskiddy facility represents Sterling's significant investment in Ireland's thriving life sciences sector. Ireland's position as a European pharmaceutical hub, combined with favorable regulatory environment and skilled workforce, provides strategic advantages for pharmaceutical manufacturing operations.
Sterling emphasizes a collaborative, science-driven culture with strong focus on employee development and customer service excellence. The company's stated values of being caring, transparent, willing, and reliable suggest a supportive work environment that prioritizes both professional growth and work-life balance.
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