QA Operations Manager

Team Horizon is seeking a QA Operations Manager who will lead the day-to-day Quality Assurance oversight of GMP manufacturing operations to ensure products are manufactured, tested, packaged, stored, and released in compliance with regulatory requirements, company standards, and the site Pharmaceutical Quality System.

Why you should apply:

• Opportunity to provide quality leadership across manufacturing, packaging, warehouse, engineering, validation, QC, and support functions.


• You will ensure effective QA presence on the shop floor, timely review of GMP documentation, robust deviation and batch record management, and proactive identification and escalation of quality risks.

What you will be doing:

• Actively participate in daily quality operations, ensuring real-time support for Manufacturing, QC, and Compliance systems teams.


• Develop, and retain talent in QA, ensuring the team possesses the right GMP expertise, problem-solving skills, and risk-based decision-making capabilities.


• Provide coaching, training, and mentorship to embed a culture of proactive quality ownership.


• 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.


• Support regulatory audits and inspections.


• Lead or support quality risk assessments related to manufacturing operations, process deviations, contamination control, facility controls, cleaning, equipment, materials, and supply continuity.


• Support operational readiness for new products, process changes, facility upgrades, and manufacturing campaigns.


• Oversee deviation management, approve CAPAs, and drive continuous improvement. Maintain a strong QA presence on the manufacturing floor to support real-time decision-making and quality risk escalation.


• Ensure appropriate quality oversight of critical process steps, line clearances, material movements, hold times, sampling, cleaning, and environmental controls.


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


• Identify and correct weaknesses, procedural gaps, and policy exceptions to optimize quality control and assurance.


• Provide training to employees on quality procedures and compliance.


• Collaborate with vendors, contractors, and suppliers to ensure they meet the organization's quality standards.


• Support departmental objectives and strategic initiatives.


• Other duties as assigned

What you need to apply:

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


• Minimum 2-3 years’ experience managing GMP Quality operations activities.


• Prior experience interfacing with and managing inspections performed by regulatory bodies. Advanced degree in Biological /Pharmaceutical science discipline.


• Experience leading deviation investigations, CAPA, change control, batch record review, and inspection readiness activities.


• Experience in leadership roles within a GMP-regulated biologics, vaccines, or sterile manufacturing environment.


• 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 ICH Specialized Knowledge or Skills


• Proficient in quality principles in a manufacturing facility


• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude.


• Have good communication skills and able to work in collaboration.


• 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.