Quality Systems Manager

Team Horizon is seeking a Quality Systems Manager who can lead the effective management, maintenance, and continuous improvement of the site's Pharmaceutical Quality System (PQS) to ensure compliance with GMP, regulatory requirements, and company standards.

Why you should apply:

• This role provides leadership and oversight of key quality systems including deviations, CAPA, change control, complaints, quality risk management, document control, training, audit management, and management review processes

What you will be doing:

• Supports and facilitates audits and regulatory inspections.


• Develops, improves, and monitors Quality Systems for the organization.


• Continuously improves areas impacted by deviations and approves appropriate CAPAs.


• Monitor system performance through KPIs and Quality Metrics.


• Drive continuous improvement initiatives across all quality systems.


• Write and revise standard operating procedures (SOPs).


• Provides direction and oversight during active processes and applies understanding of European Union (EU) Veterinary Medicinal Products regulations related to Veterinary Medicinal Products and Continuous improvement.


• Decision Making/Problem Solving - Identify and understand issues, problems and opportunities and compare data from different sources to draw conclusions and develop solutions consistent with the facts. Natural influencer and ability to form strong relationships cross functionally.


• Correct weaknesses, ineffective procedures, and discrepancies and performs or approves appropriate corrective actions


• Write, review, and revise Standard Operating Procedures (SOPs)


• Provides Training to new employees.


• Able to work effectively with team members and other professionals such as vendors, contractors, or suppliers with the aim of ensuring their products or services meet the organization’s quality standards


• Support departmental objectives and strategic initiatives.


• Proficiency with Microsoft applications, including Word and Excel and environmental systems.


• Other duties as assigned

What you need to apply:

• Minimum 6 – 8 years of relevant experience in biotech or pharmaceutical industry


• Minimum 2 to 3 years’ experience managing GMP Quality Systems.


• Prior experience interfacing with and managing inspections performed by regulatory bodies.


• Advanced degree in Biological /Pharmaceutical science discipline. 


• Demonstrated success in quality management leadership and the resolution significant quality /technical challenges.


• Expertise in EU GMP, regulatory inspections, risk-based QA strategies, and digital transformation in quality systems. 


• Proven ability to lead teams, optimize QA processes, and drive a culture of continuous improvement.


• Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, EMA, and ICICH Specialized knowledge or Skills 


• Proficient in quality principles in a manufacturing facility with a strong quality mindset and proactive approach.


• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude. • Have good communication skills and able to collaborate effectively.


• Effective time management; deliver results on time.


•  Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook).


• Has the ability to read, write and communicate in English.