Come and Save Lives with Us!
SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies.
For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes.
Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.
Having the right culture is as important to us as having the right portfolio. We are guided by our four values:
- We make patients our priority
- We act with accountability and integrity
- We work together as one team
- We look for better ways forward
By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.
Broad Overview
The Supplier & Distribution Quality Associate Director is a global governance role responsible for defining, implementing, and continuously improving quality systems related to supplier qualification, external partner oversight, and distribution activities across pharmaceutical and medical device operations. This role ensures compliance with UK, EU, US and other internationally relevant pharmaceutical and medical device regulatory requirements. The position operates within a global quality framework, partnering with regional stakeholders to ensure compliant execution of operational activities while maintaining central ownership of processes, standards, and governance.
Your responsibilities include:
Global Quality Process Ownership & Governance
- Act as global process owner for supplier and distribution quality, accountable for end-to-end design, standardisation, governance, and performance.
- Define global frameworks, procedures, and operating models, including clear roles, responsibilities, and escalation pathways.
- Define effective global KPIs and drive continuous improvement.
Supplier Quality Management Governance
- Own the global supplier lifecycle process, from initial qualification, through approval, and ongoing performance management.
- Define risk-based approaches and ensure consistent implementation through oversight of local SMEs.
External Audit Management Governance
- Own governance of the global external audit programme, including standards, planning, execution, and follow-up processes.
- Define effective global KPIs and drive continuous improvement.
Distribution Quality Governance
- Own the global distribution quality process, including third-party oversight, performance monitoring, and incident management
- Drive consistency and continuous improvement across distribution networks.
- Collaboration with local stakeholders and process owners
- Define and maintain the global vs local operating model for process ownership and execution.
- Provide oversight and direction to local stakeholders and SMEs, ensuring alignment and effective escalation.
Inspection and audit readiness
- Ensure global processes are consistently inspection ready.
- Support inspections and audits, ensuring timely and effective management of observations and actions
M&A Integration
- Lead integration of supplier and distribution quality processes following acquisitions.
- Assess, align, and embed acquired entities into global standards.
Continuous Improvement and Risk Management
- Drive a risk-based, data-driven approach to process management.
- Monitor performance trends, identify risks, and implement improvements across systems and processes.
The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
To be successful in this role, you should demonstrate:
- Degree (or equivalent) in a scientific field desirable.
- Extensive experience in the pharmaceutical industry (typically 10+ years), including significant exposure to supplier quality management (e.g. API, raw materials, packaging, CMOs) and distribution quality. Experience in the medical device industry is highly desirable.
- Demonstrated experience operating within a global quality governance or process ownership role, with accountability for designing and implementing standardised processes across multiple regions.
- Strong working knowledge of EU/UK/US GMP and GDP requirements and associated regulatory expectations for supplier qualification and distribution oversight.
- Proven experience leading or overseeing global supplier qualification programmes, including risk-based approaches, performance management, and third-party oversight.
- Experience with external audit programme management, including audit strategy, execution oversight, and remediation of findings.
- Demonstrated involvement in regulatory inspections and audits (e.g. MHRA, EMA, FDA), including preparation, hosting, and response management.
- Experience in M&A integration or large-scale quality system transformation desirable, including harmonisation of acquired quality systems into global frameworks.
- Recognised qualification as a Lead Auditor and/or completion of Responsible Person (RP) training is desirable.
- Experience leading cross-functional and cross-regional projects, including implementation of quality systems, digital tools, or process improvements.
Skills & Experience
- Strong strategic thinking and process ownership mindset, with the ability to translate regulatory requirements into scalable global frameworks.
- Demonstrated ability to influence without authority across a matrix organisation, including senior stakeholders, SMEs, Qualified and Responsible Persons.
- Excellent stakeholder management and communication skills, with the ability to provide clear direction and challenge constructively where required.
- Highly developed risk management and decision-making capability, with a pragmatic and balanced approach to compliance and business needs.
- Strong analytical skills, with the ability to interpret data, identify trends, and drive data-driven continuous improvement.
- Proven ability to lead through complexity and ambiguity, particularly in global and multi-regional environments.
- High level of credibility and confidence in inspection and audit environments.
- Ability to drive standardisation while respecting local regulatory requirements and operational realities.
- Resilient, self-directed, and results-oriented, with a strong sense of accountability and ownership.
- Continuous improvement mindset, with a track record of challenging existing practices and implementing sustainable improvements.
Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.
