Position Details

The Quality Operations Manager is responsible for leading the day-to-day QA oversight of GMP manufacturing operations to ensure products are manufactured, tested, packaged, stored & released in compliance with regulatory requirements, company standards & the site Pharmaceutical Quality System.

This role provides quality leadership across manufacturing, packaging, warehouse, engineering, validation, QC & support functions. The role ensures effective QA presence on the shop floor, timely review of GMP documentation, robust deviation, batch record management, proactive identification & escalation of quality risks.

Roles & Responsibilities:
•Participate in daily quality operations, ensuring real-time support for Manufacturing, QC & Compliance systems teams. 
•Develop & retain talent in QA, ensuring the team possesses the right GMP expertise, problem-solving skills & risk-based decision-making capabilities. 
•Provide coaching, training & mentorship to embed a culture of proactive quality ownership.
•Identify & understand issues, problems & opportunities & compare data from different sources to draw conclusions & develop solutions. Natural influencer & ability to form strong relationships.
•Regulatory audits & inspections. 
•Lead or support quality risk assessments related to manufacturing operations, process deviations, contamination control, facility controls, cleaning, equipment, materials & supply continuity.
•Support operational readiness for new products, process changes, facility upgrades & manufacturing campaigns.
•Oversee deviation management, approve CAPAs & drive continuous improvement. 
•Strong QA presence on the manufacturing floor to support real-time decision-making & quality risk escalation.
•Ensure appropriate quality oversight of critical process steps, line clearances, material movements, hold times, sampling, cleaning & environmental controls.
•Write, review & revise SOPs. 
•Identify & correct weaknesses, gaps & policy exceptions. 
•Train employees on procedures & compliance. 
•Collaborate with vendors, contractors & suppliers to ensure they meet quality standards. 
•Support departmental objectives & strategic initiatives.
•Other duties as assigned.

Education and/or Work Experience:
•Minimum 6–8 years of relevant experience in biotech/pharmaceutical industry
•Minimum 2-3 years’ experience managing GMP Quality operations activities.
•Prior experience interfacing with & managing inspections performed by regulatory bodies.
•Advanced degree in Biological/Pharmaceutical science discipline. 
•Experience leading deviation investigations, CAPA, change control, batch record review & inspection readiness activities.
•Experience in leadership roles within a GMP-regulated biologics, vaccines or sterile manufacturing environment. 
•Demonstrated success in quality management leadership & the resolution significant quality/technical challenges.
•Expertise in EU GMP, regulatory inspections, risk-based QA strategies & digital transformation in quality systems. 
•Proven ability to lead teams, optimize QA processes & drive a culture of continuous improvement.
•Strong working knowledge of Industry Compendia, regulations, & standards including USP / Ph. Eur, GMP, EMA & ICH

Knowledge/Skills: 
•Proficient in quality principles in a manufacturing facility.
•Must be able to work under pressure & 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.