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 interventions

Outcomes:

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 process
guidelines 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 team

Analyse:

Ensure KPIs set by the team are in line with the process change management and provide timely feedbacks on the process

Early Risk Management:

Identification and Evaluate High Risk Projects within the organization and provide timely recommendation to the projects and the senior management

Metrics:

Educate and Ensure the quality metrics are provided to the organization baseline

EBITDA Leakage:

Bring down the EBITDA Leakage with recommendations and tight governance

Process 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 organization

Skill 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:

Job Description 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 • Bachelor’s/Master’s 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.