GSK
manufacturing
OQManager(OperationalQuality)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“OQ Manager (Operational Quality) at GSK. Skills: Operational Quality, people leadership, continuous improvement, stakeholder management. manage Operational quality assurance activities across the site. coach and manage a team of Operational Quality Advisors and Quality oversight specialists”
Industry & Context.
quality investigations; incidents are managed appropriately and effectively; reduce defects and waste
What They're Looking For.
Must Have
Degree in a relevant scientific, technical or engineering discipline, or equivalent experience, Experience in pharmaceutical manufacturing quality, including operational QA, Solid working knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for manufacturing sites, Practical experience with process, equipment and/or computer system validation, Demonstrable people leadership experience, including coaching and team development, communication and stakeholder management skills
Nice to Have
A fully qualified QP (Qualified Person)
What You'll Do.
manage Operational quality assurance activities across the site
coach and manage a team of Operational Quality Advisors and Quality oversight specialists
ensure products are manufactured and released to GSK and regulatory standards
partner with manufacturing
engineering and site leadership to keep processes and equipment within regulatory expectations
help the site deliver safe
Leading and developing the Operational Quality Assurance team
Overseeing material release process
Ensuring quality investigations and incidents are managed appropriately and effectively
Managing periodic reviews
Acting as primary interface between Quality and site functions
Providing quality oversight during operations
Driving continuous improvement to reduce defects and waste
How You'll Work.
Team & Collaboration
partner with manufacturing, engineering and site leadership; Acting as primary interface between Quality and site functions; partnering with Quality oversight specialists
Communication Scope
Effective written and verbal communication; excellent interpersonal skills
Process & Methodology
resource planning
Full Job Description
The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at GSK Irvine Manufacturing Site. The Quality function at GSK plays a critical role in ensuring our products meet the highest standards of safety, efficacy, and compliance. As part of this team you will uphold our commitment to delivering high-quality medicines and vaccines, and healthcare products to patients and consumers around the world. **Position Summary** As Operational Quality (OQ) Manager you will manage Operational quality assurance activities across the site. You will coach and manage a team of Operational Quality Advisors and Quality oversight specialists to ensure products are manufactured and released to GSK and regulatory standards. You will partner with manufacturing, engineering and site leadership to keep processes and equipment within regulatory expectations. We seek a practical, curious manager who improves systems, develops people and helps the site deliver safe, high-quality product. **Direct Reports –** As team-manager you will have approximately 10 direct reports. **Responsibilities (include..,):** * Leading and developing the Operational Quality Assurance team (including succession planning and coaching). * Overseeing material release process to ensure effective and compliant review of batch documentation, Laboratory results and all other documentation associated with certification and/or release of materials. * Ensuring quality investigations and incidents are managed appropriately and effectively. * Managing periodic reviews (including Periodic Product Reviews – PPRs), and tracking schedules and trends. * Acting as primary interface between Quality and site functions (to support investigations, CAPAs and change control). * Providing quality oversight during operations, partnering with Quality oversight specialists to maintain compliant release and quiet hour activities. * Driving continuous improvemen
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