Manager Ii

Role Proficiency Function as an independent consultant to projects by helping to pick right suite of processes and best practices with needed tailoring at every stage of the project life cycle Advise senior delivery leaders on process improvements and provide Delivery intelligence to leadership through processes and interventionsOutcomes Facilitate and review project artifacts activities that enables project execution along the process path minimizing execution risk on projects Report to appropriate levels of hierarchy at the right time execution risks and impact to project commitments to customer Facilitate perform root cause analysis at program project level derive action items for recurring non-compliances and bring to closure Aid sales as well delivery teams in responding to RFPs MSAs and SOWs on a need basis Inputs on improvements for PM practices PMs towards PM Competency framework To participate in customer visits to project contribution of EPEX Team at organization level Create opportunities for customer interaction at account project level Embrace new ideas that produce outstanding results to teams which in turn reaches to customers Perform additional responsibilities as and when required based on business needs Measures of Outcomes No of Detailed Project Reviews conducted No of Risks identified and update the Risky Project Tracker No of Client visit participated No of SLA breaches and Penalties captured and reported to senior management Outputs Expected Measure Evaluate all UST processguidelines and best practices for its intent and business value so that consultancy can be provided to delivery teams as and when required based on the inputs shared by the teamAnalyse Ensure KPIs set by the team are in line with the process change management and provide timely feedbacks on the processEarly Risk Management Identification and Evaluate High Risk Projects within the organization and provide timely recommendation to the projects and the senior managementMetrics Educate and Ensure the quality metrics are provided to the organization baselineEBITDA Leakage Bring down the EBITDA Leakage with recommendations and tight governanceProcess Presentation Prepare a process presentation with all relevant details Deliver process presentations to Customers and delivery leadership Project Review To perform Formal Project Reviews on Critical projects identified across the organizationSkill Examples Ability in defining process frameworks at the project or program level Estimation skills using Function point analysis Ability to perform and conduct root cause analysis sessions Agile specialist Scrum Kanban Ability to manage teams of over 15 Ability to influence without authority Delivery process presentations to Customers and delivery leadership Quantitative management techniques for all SDLC methodologies under skills Data Analysis and Intelligence Strong and proven interpersonal and collaboration skills Analytical and problem-solving ability Process driven approach Knowledge Examples Knowledge of Agile Methods - Scrum and Kanban Change Management Process Discipline Additional Comments Manager - Digital Quality Systems Data Governance This role will evolve from overseeing the implementation of our Laboratory Information Management System LIMS and its integration with Quality Management Systems QMS and NetSuite ERP into a long-term system owner and custodian of digital quality excellence The role will be pivotal in managing the lifecycle of quality systems ensuring regulatory compliance promoting adoption and driving ongoing digital transformation across quality and lab operations We are seeking a highly motivated QA Specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility This role is pivotal in driving digitalisation across Quality Control QC Production and QA operations ensuring seamless data collection validation software adoption and system compliance The ideal candidate will work cross-functionally with manufacturing QA QC IT and Regulatory Affairs to enhance efficiency productivity and regulatory readiness Reports to Head Quality Assurance Dotted Line Reporting Chief Information Officer Key Responsibilities 1 Software Implementation Validation Lead or support the implementation and validation of electronic systems across QA QC Production and Supply Chain e g LIMS MES eBMR ERP CDS QMS Lead the deployment validation maintenance and support of LIMS across multiple laboratory sites Partner with Quality Control QC Quality Assurance QA IT and Laboratory Operations to define user requirements workflows and system improvements Manage configuration changes upgrades and enhancement projects in LIMS ensuring compliance with GxP and regulatory requirements Ensure all systems comply with GAMP 5 21 CFR Part 11 EU Annex 11 and Data Integrity standards Draft and review documentation such as URS FDS IQ OQ PQ protocols traceability matrices and validation reports LIMS Management Lead the deployment validation maintenance and support of LIMS across multiple laboratory sites Partner with Quality Control QC Quality Assurance QA IT and Laboratory Operations to define user requirements workflows and system improvements Manage configuration changes upgrades and enhancement projects in LIMS ensuring compliance with GxP and regulatory requirements Manage software vendor relationships renewals SLAs and support issue escalations Optimize licensing and plan budget for system operations and enhancements 2 Quality Oversight Data Integrity Oversee digital workflows ensuring they align with SOPs batch records and regulatory expectations Monitor and audit electronic data for integrity traceability and compliance Support CAPAs and investigations related to software failures or deviations involving digital systems 3 Digital Process Improvement Partner with operations and IT teams to identify process automation opportunities and improve data flow and transparency Contribute to the development of dashboards analytics tools and AI ML-based insights for predictive quality and productivity 4 Training Change Management Lead training initiatives to support software onboarding and proper usage by shop-floor staff Act as a digital transformation champion promoting system adoption and reducing manual dependencies 5 Regulatory Interface Interface with internal Regulatory Affairs to support submissions inspections and responses to queries involving computerised systems Prepare and participate in regulatory audits USFDA EMA WHO CDSCO etc related to data management and software validation Qualifications Experience Bachelors Masters in Life Sciences Computer Science or Pharmaceutical Sciences 10 years in pharma biotech industry with experience in LIMS QMS ERP systems in a GMP-regulated Pharma Biotech environment Experience with LIMS systems Strong understanding of GxP 21 CFR Part 11 Annex 11 and CSV principles Proven record of system ownership post-implementation and cross-functional leadership Skills Competencies Mastery of digital quality systems and data governance Strong project and change management skills Excellent communication leadership and collaboration abilities Strong analytical skills and comfort with reporting and dashboards Strong knowledge of laboratory workflows and QC operations Skills Quality Control Quality Engineering LimsAbout Company UST is a global digital transformation solutions provider For more than 20 years UST has worked side by side with the worlds best companies to make a real impact through transformation Powered by technology inspired by people and led by purpose UST partners with their clients from design to operation With deep domain expertise and a future-proof philosophy UST embeds innovation and agility into their clients organizations With over 30 000 employees in 30 countries UST builds for boundless impactxe2x80x94touching billions of lives in the process