Quality and Regulatory Affairs Director

Unimed Maritime Solutions; Rotterdam; On-site; EUR 150,000 - 190,000; Full time

Job summary

Unimed Maritime Solutions is seeking a senior leader to steer global compliance, regulatory and quality programs. You will ensure GDP, GMP and ISO standards are embedded across operations, with governance of AI-enabled systems and data integrity.

Reporting to the CEO and serving on the Senior Management Team, you will lead a cross-functional quality and regulatory affairs function, manage inspections, CAPAs, audits and supplier qualification, and travel 20–30% to Unimed sites and partners.

Qualifications

• Bachelor's degree in Pharmacy, Health Sciences or a related scientific discipline.
• 8+ years of senior-level compliance, regulatory and quality experience in regulated industries.
• Strong knowledge of GDP, GMP, ISO standards and Quality Management Systems.
• Experience with sanctions screening, due diligence and multi-jurisdiction licensing.
• Fluent English written and spoken; travel 20–30%.

Responsibilities

• Lead regulatory compliance, maintain registrations and licenses with authorities.
• Own and improve the global Quality Management System across GDP, ISO standards.
• Develop and resource the Quality and Regulatory Affairs team across regions.
• Oversee CAPAs, deviations, changes, root-cause investigations and remediation.
• Oversee sanctions screening and due diligence for customers and vendors.
• Lead audits and inspections and drive governance of AI-enabled systems.

Skills

English proficiency

Regulatory leadership

Quality management

CAPA management

Data governance

Audits & inspections

Risk analysis

Cross-functional leadership

Education

Bachelor's degree (Pharmacy/Health Sciences)

Tools

GAMP 5

Job description

Lead Unimed's global compliance, regulatory and quality program, ensuring the business meets applicable licensing, sanctions, GDP, GMP and internal quality requirements. The role is the senior subject matter expert for these areas and works with business leaders to embed practical controls across day-to-day operations. Reporting to the Chief Executive Officer, the role is a member of the Senior Management Team, serves as the designated Management Representative for the Quality Management System, and is accountable for the governance of AI-enabled and data-driven systems used in regulated processes.

Key Responsibilities

• Lead regulatory compliance, maintain required registrations and licenses and serve as a key contact for the relevant regulatory authorities, and represent Unimed in relevant industry associations and standards bodies.
• Own and continuously improve the global Quality Management System, ensuring policies, procedures and controls meet applicable GDP, ISO, customer and business requirements.
• Lead, develop and resource the Quality and Regulatory Affairs team, setting direction for corporate, regional and site quality managers and coordinating quality activities across Unimed entities.
• Oversee CAPAs, deviations, change controls, root cause investigations and remediation, with timely escalation of significant or recurring issues.
• Manage the global quality complaint and product recall processes, including regulatory assessment, documentation, mock recalls and follow-up actions, ensuring potential recalls are escalated promptly and recall decisions are made, executed and documented without delay.
• Lead regulatory inspections and quality audits, coordinate preparation and responses, and track findings through closure.
• Run a risk-based internal audit programme across Unimed sites and distribution centres to identify and mitigate critical-to-quality and regulatory risks before they disrupt operations.
• Own global policies and procedures governance, document control and review cycles, and support implementation and training for new or revised procedures.
• Oversee global sanctions compliance and screening for customers, vendors, vessels and other relevant parties, including higher-risk reviews and escalation.
• Maintain the global regulatory license register and coordinate renewals and new licensing requirements across jurisdictions.
• Own risk-based due diligence standards for customers, vendors and other third parties, ensuring reviews, approvals and exceptions are properly documented.
• Own supplier and product qualification, including the vendor quality audit programme for strategic suppliers and service providers, ensuring sourced products meet required specifications, good practices and regulations.
• Provide oversight and guidance on GDP requirements relating to receipt, storage, handling, distribution and other applicable activities.
• Monitor emerging regulatory, compliance and quality risks and provide clear reporting and recommendations to executive leadership, including regular reporting of quality and compliance KPIs (complaints, deviations, change controls, training, audit observations and overdue actions).
• Chair periodic quality management reviews and track agreed actions through to completion.
• Approve the use of AI in regulated (GDP) processes, ensuring each use case is risk-assessed, has defined human oversight and accountability, and is documented before deployment.
• Own the validation of AI-enabled and other computerised systems supporting regulated activities, including validation strategy, change control, ongoing performance monitoring and periodic review.
• Set data governance and data integrity standards (ALCOA+) for regulated quality and compliance records, including access controls, audit trails and retention, across all systems.
• Develop practical training and promote a strong culture of quality, compliance and accountability across the organization.
• Lead workplace health and safety standards at Unimed sites, ensuring hazards and incidents are reported, investigated and controlled in line with Unimed policy and local regulatory requirements, and that staff and contractors complete required safety training.

Key Working Relationships

Works closely with the Chief Executive Officer and Senior Management Team, Operations, Commercial, Purchasing, Finance, Legal, Human Resources, local site leaders, regulators, customers, vendors and external compliance and quality partners. Leads the Quality team, with corporate Quality Managers as direct reports and regional and site Quality Managers as functional reports.

Qualifications & Experience

• Bachelor's degree in Pharmacy, Health Sciences or a related scientific discipline; a recognised quality or regulatory qualification is an advantage.
• At least 8 years of senior-level compliance, regulatory and quality experience in pharmaceuticals, healthcare, medical supply or another regulated industry.
• Strong knowledge of UK pharmaceutical regulation and MHRA requirements, with experience as, or working closely with, a UK Responsible Person or equivalent regulated role.
• Strong working knowledge of GDP, GMP, ISO standards and Quality Management Systems.
• Practical experience managing CAPAs, deviations, complaints, recalls, inspections, audits, supplier qualification, policies and procedures and document control.
• Working knowledge of computerised system validation (for example GAMP 5), data integrity principles and the governance of AI in regulated environments.
• Experience with sanctions screening, third-party due diligence, and regulatory licenses or registrations across multiple jurisdictions.
• Experience working across countries, legal entities and functions in a complex international business.
• Fluent written and spoken English.
• Willingness to travel (approximately 20-30%) to Unimed sites and supplier locations for audits and inspections.
• Sound regulatory, quality and compliance judgment, with high integrity and professional independence.
• Practical, risk-based and business-oriented approach to problem-solving and decision-making.
• Strong analytical skills, including root cause analysis, trend identification and assessment of systemic risk.
• Clear written and verbal communication, with the ability to translate complex requirements into practical expectations.
• Strong organization, attention to detail and ability to manage multiple priorities and regulatory deadlines.
• Confidence working with executive leadership and constructively challenging decisions where material risk exists.
• Ability to work effectively across functions, cultures and jurisdictions.
• Builds and develops capable quality teams, with a positive, supportive and continuous-learning mindset in a fast-paced environment.