Gsk
Pharmaceuticals
TeamLead,TherapeuticAreaQuality
“Team Lead, Therapeutic Area Quality at Gsk. Skills: Therapeutic Area Quality, Quality Business Partners, Quality strategy, Submission readiness, Inspection readiness. Lead a team of Quality Business Partners. Deliver independent quality expert support”
What You'll Achieve.
Positively impact health of 2.5 billion people; Accelerate significant assets
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Bachelor's degree or equivalent in scientific or quality-related field, Experience in pharmaceutical industry and/or quality assurance, Minimum 3 years supervisory/management experience, Knowledge of quality assurance principles, Knowledge of (quality) risk management principles, Knowledge of quality by design principles, Knowledge of GLP, GCP, pharmacovigilance/drug safety, Knowledge of regulatory requirements, Analytical skills, Organizational skills, Planning skills, Broad knowledge in oncology, Broad knowledge in immunology, Broad knowledge in respiratory, Broad knowledge in vaccine
Nice to Have
Extensive experience supporting regulatory authority inspections, Broad knowledge of Risk-based quality management, Broad knowledge of root cause analysis, Broad knowledge of quality narrative briefs concepts, Broad knowledge of quality narrative briefs methodology, Digital savviness, Experience with AI/ML, Experience with data analytics, Ability to work effectively in international multicultural matrix organization, Effective communication skills, Negotiation skills, Customer management skills, Experience with Veeva QMS, Experience with CTMS, Experience with Veeva Doc
What You'll Do.
Lead a team of Quality Business Partners
Deliver independent quality expert support
Provide input into quality strategy
Ensure quality is designed into programs
Ensure quality is designed into projects
Define quality activities for submission readiness
Define quality activities for inspection readiness
Evaluate strategic approach
Drive changes in R&D QuRE processes
Modify quality strategy
Identify continuous quality improvements
Drive continuous quality improvements
Perform risk assessments
Analyze trends/metrics
Perform root cause analysis
Provide input into global audit plan
Communicate critical quality risks
Communicate critical quality issues
Communicate potential misconduct
Drive Quality by Design implementation
Support preparation of health authority inspections
Support execution of health authority inspections
Support close out of health authority inspections
Demonstrate implementation of quality strategy
Participate in Due Diligence
Provide expertise in Due Diligence
Support development of annual goals
Support development of objectives
Review R&D Quality strategy
Revise R&D Quality strategy
Review Risk Management strategy
Revise Risk Management strategy
Lead functional initiatives
Support functional initiatives
Maintain awareness of international GLP regulations
Maintain expertise in international GLP regulations
Maintain awareness of international GCP regulations
Maintain expertise in international GCP regulations
Maintain awareness of international GVP regulations
Maintain expertise in international GVP regulations
Maintain awareness of internal policies
Maintain expertise in internal policies
Maintain awareness of internal SOPs
Maintain expertise in internal SOPs
Influence external environment through interactions with regulators
Influence external environment through interactions with trade associations
Influence external environment through interactions with professional societies
How You'll Work.
Team & Collaboration
Quality Business Partner Leadership Team; Key stakeholders; Business partner; QuRE management; Health authorities; International environment; Global quality
Communication Scope
Effective communication; Negotiation
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