GSK
Director,OperationalQuality
“Director, Operational Quality at GSK. Skills: Operational Quality, Quality Systems, cGMP, Regulatory Requirements. Oversee end-to-end quality oversight of production activities. Ensure products manufactured, tested, released align with GSK standards”
What You'll Achieve.
Ensure uncompromising compliance across manufacturing and Quality Operations; Ensure products consistently meet license commitments and quality expectations; strengthening quality culture; driving performance, engagement, accountability, and continuous improvement
Industry & Context.
Ability to analyse complex data; drive continuous improvement; lead teams under pressure
What They're Looking For.
Must Have
Bachelor’s degree in Life Sciences (e.g., Biotechnology, Biology, Pharmaceutical Sciences, Physical Sciences), Demonstrated regulated industry experience (pharmaceuticaliotech) combined with experience in leadership roles, working knowledge of cGMP’s/FDA and other regulatory requirements e. g ICH Guidelines 8, 9, 10, 11 including RoW standards, WHO, Eudralex, etc., Demonstrated experience leading Quality Assurance teams, managing inspections, and navigating complex quality and operational decision making, Proven expertise in Pharmaceutical Quality Systems, batch release governance, deviation and change control management, and technical investigations, communication skills and the ability to influence and collaborate across multiple disciplines and seniority levels in a highly regulated environment, Ability to analyse complex data, drive continuous improvement, and lead teams under pressure while maintaining a culture of quality and compliance, business and operational knowledge and acumen
Nice to Have
Advanced degree (Master’s or PhD) in a relevant Life Science or Engineering discipline, Experience operating in large, matrixed global organisations, Demonstrated ability to lead change, elevate quality culture, and drive digital and operational transformation
What You'll Do.
Oversee end-to-end quality oversight of production activities
Ensure products manufactured
released align with GSK standards
Lead Operational Quality function
Drive effectiveness of key Quality Systems
continuous improvement
Strengthen quality culture
Ensure site delivers safe
high-quality medicines
Provide leadership across Operational Quality
high-integrity decision making
Ensure products released comply with regulatory filings
assure accuracy of batch documentation
Oversee management of investigations
Ensure real-time quality oversight of manufacturing operations
Govern the change control process
Ensure Quality systems
policies remain current
Support successful regulatory and internal inspections
develop high-performing Operational Quality
Support operational and budget planning for OQ function
Apply GPS tools to identify improvement opportunities
How You'll Work.
Team & Collaboration
Collaborate across multiple disciplines and seniority levels
Communication Scope
communication skills; ability to influence and collaborate
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