Quality & Compliance Officer BeNeSca

SmartRecruiters, Inc.; Niel; Hybrid; EUR 75,000 - 110,000; Full time

Benefits offered by this job

32 days of leave

Hybrid working model

Benefits package

Job summary

SmartRecruiters, Inc. is seeking a Quality & Compliance Officer BeNeSca to act as local expert for quality and compliance across the BeNeSca affiliate.

You will maintain the Quality Management System, oversee GDP compliance, CAPAs and deviations, and support Pharmacovigilance, Regulatory Affairs and HSE activities. The role offers a collaborative, international environment and a flexible hybrid working model.

Qualifications

• Master’s degree in Veterinary Medicine, Pharmacy, Life Sciences, Biomedical Sciences, Biology or a related scientific discipline.
• Experience in Quality Assurance within the pharmaceutical, veterinary pharmaceutical or life sciences industry.
• Strong understanding of quality systems, GDP requirements and compliance processes.
• Excellent organisational and analytical skills with a strong attention to detail.
• Able to work independently while building strong relationships with a wide range of stakeholders.
• Strong communication and language skills (Dutch, French and English) with the ability to communicate clearly and effectively across different functions and countries.

Responsibilities

• Maintain the Quality Management System and oversee day-to-day quality operations across the affiliate.
• Ensure all affiliate operations comply with GDP requirements, local regulations and company quality standards.
• Manage deviations, change controls and CAPAs.
• Coordinate self-inspections, support audit readiness and ensure inspection and recall preparedness for veterinary medicinal products.
• Support and oversee administrative batch release activities in accordance with procedures.
• Manage product and customer quality data and ensure handling of complaints.
• Evaluate disposition of returned/rejected/falsified products and escalate quality concerns.
• Provide quality-related expertise to commercial teams.
• Ensure training programmes are implemented and promote a strong culture of quality and compliance.

Skills

Quality Assurance

GDP Compliance

Analytical skills

Organisational skills

Independent worker

Multilingual

Stakeholder management

Attention to detail

Education

Master’s degree in Veterinary Medicine / Life Sciences

Job description

We’re a top-10 global animal health company with a family business mindset.

Every day, we make life better for pets, their owners and the veterinary teams who care for them.

Job Description

What you’ll do

As Quality & Compliance Officer BeNeSca, you'll act as the local expert for quality and compliance while collaborating with colleagues across multiple functions and countries.

1. Quality Management & Compliance

As the primary local quality contact and Responsible Person for Quality Assurance, you will maintain the Quality Management System and oversee day-to-day quality operations across the affiliate.

• Ensure all affiliate operations comply with applicable GDP requirements, local regulations and company quality standards.
• Maintain and continuously improve the local Quality Management System.
• Manage deviations, change controls and corrective and preventive actions (CAPAs).
• Coordinate self-inspections, support audit readiness and ensure inspection and recall preparedness for veterinary medicinal products.
• Support and oversee administrative batch release activities in accordance with applicable procedures.
• Manage product and customer quality data and ensure the effective handling of customer complaints, including logistics, commercial and quality-related complaints.
• Evaluate and decide on the disposition of returned, rejected or potentially falsified veterinary medicinal products, escalating product quality concerns to Group Quality where appropriate.
• Support commercial teams by providing quality-related expertise and information that contributes to customer satisfaction and business objectives.
• Ensure training programmes are implemented and promote a strong culture of quality and compliance throughout the affiliate.
• Stay informed about local and European GDP developments and regulatory requirements.

2. Health, Safety & Environment (HSE)

You will act as the local lead for Health, Safety & Environment activities and contribute to a safe and environmentally responsible workplace in close collaboration with internal stakeholders.

• Ensure compliance with HSE policies, procedures and legal requirements.
• Identify, assess and report workplace hazards, risks, incidents and near misses.
• Promote a strong safety culture and act as a role model for safe and environmentally responsible behaviours.
• Participate in HSE training, audits, inspections and corrective action programmes.
• Contribute to achieving the company's HSE objectives and sustainability goals.

3. Pharmacovigilance support

You will support the Regulatory Affairs & Pharmacovigilance Officer in maintaining a robust and compliant Pharmacovigilance system and contributing to Pharmacovigilance activities across the affiliate.

• Contribute to the establishment, maintenance and continuous improvement of the affiliate's Pharmacovigilance Quality Management System.
• Support the preparation and maintenance of Pharmacovigilance procedures and related quality documentation, including local PV SOPs.
• Assist in the collection, documentation, assessment and reporting of adverse events and safety-related information in line with regulatory requirements and company procedures.
• Support the management of Pharmacovigilance deviations and the timely implementation of CAPAs.
• Act as backup for Pharmacovigilance responsibilities and assume designated LRRP duties when required to ensure ongoing compliance.
• Support Pharmacovigilance interactions with national authorities and internal stakeholders where required.

4. Regulatory Affairs support

You will provide backup support for Regulatory Affairs activities and contribute to maintaining regulatory compliance across the affiliate.

• Act as backup for the Regulatory Affairs & Pharmacovigilance Officer and assume priority Regulatory Affairs responsibilities when required.
• Support the administrative management of marketing authorisations for veterinary medicines.
• Maintain regulatory databases and product platforms, ensuring accurate and up-to-date information.
• Provide regulatory guidance and support for promotional materials, marketing activities and related compliance reviews.
• Contribute to the harmonisation of regulatory, quality and pharmacovigilance processes, promoting an integrated approach across these functions.

Qualifications

Who you are

• Master’s degree in Veterinary Medicine, Pharmacy, Life Sciences, Biomedical Sciences, Biology or a related scientific discipline.
• Experience in Quality Assurance within the pharmaceutical, veterinary pharmaceutical or life sciences industry.
• Strong understanding of quality systems, GDP requirements and compliance processes.
• Excellent organisational and analytical skills with a strong attention to detail.
• Able to work independently while building strong relationships with a wide range of stakeholders.
• Strong communication and language skills (Dutch, French and English) with the ability to communicate clearly and effectively across different functions and countries.
• Customer-focused, service-oriented and able to build credibility with internal and external stakeholders.
• Stress-resistant, able to manage multiple priorities and deadlines in a regulated environment.
• Patient, accurate and thorough, with a strong focus on quality and compliance.
• A proactive attitude and passion for continuous improvement.

Additional Information

• A meaningful specialist role with a direct impact on quality, compliance and animal health across the BeNeSca region.
• Broad exposure to Quality Assurance, Health & Safety, Pharmacovigilance and Regulatory Affairs.
• An attractive benefits package.
• 32 days of leave and a flexible hybrid working model, supporting a healthy work-life balance.
• The opportunity to collaborate with both local and international teams and subject matter experts.
• An international environment with strong connections to Group Quality, Regulatory Affairs and Pharmacovigilance functions.
• A global company with a family-oriented culture, combining an international mindset with a personal and collaborative working environment.
• A collaborative team of passionate animal lovers with a strong team spirit and regular team activities.
• Room for initiative, ownership and professional development.
• And yes, you can bring your furry friend to our state-of-the-art office in Niel!