Manager – Business Application

Piramal Pharma; Mumbai; On-site; INR 2,000,000 - 4,000,000; Full time

Job summary

Piramal Critical Care in Mumbai is seeking a Manager – PV & Quality Applications to own end-to-end management of PV and Quality software. You will liaise with PV, Quality, and IT teams, coordinate with vendors, and ensure validated, compliant systems across global sites.

The role requires leading design, implementation, upgrades, data migrations, and training, while supporting regulatory audits and budget inputs for sustained value and continuous improvement.

Qualifications

• B.S. in IT/CS/Engineering or Life Sciences with 8+ years in IT project management.
• Experience in PV, Quality or regulated pharma environments.
• Experience with PV, Quality, ERP and integration applications; Argus/Ennov/Axway/SAP preferred.
• Knowledge of computer system validation lifecycle, GAMP 5 and data integrity.

Responsibilities

• Lead implementation, upgrade, and integration of PV and Quality applications.
• Collaborate with PV, Quality, Mfg.site and global IT teams; manage vendors.
• Define requirements, validate changes, and ensure regulatory compliance.
• Support audits, CSV activities, CAPAs and status reporting.

Skills

IT Project Management

IT Support Delivery

Enterprise Application Management

PV & Quality Applications

GxP systems

Stakeholder coordination

Education

B.S. in Information Technology

Bachelor's in CS or Engineering

Life Sciences background

Tools

Argus

Ennov

Axway

SAP

Job description

Be the First to ApplyDivisionPiramal Critical CarePiramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.For more details, please visit https://www.piramalcriticalcare.com/global/Job TitleManager – Business ApplicationJob DescriptionThe Business Applications Manager - PV & Quality Applications acts as the liaison between PCC Pharmacovigilance, Quality business users, software support vendors and internal PCC IT support teams. The ideal candidate will own end-to-end application management, implementation, validation coordination, enhancement, integration and support of GxP/non-GxP business applications such as Argus, Ennov, Axway, Quality applications and other relevant platforms supporting PCC business processes.Business: Piramal Critical CareDepartment: Information TechnologyLocation: Kurla, MumbaiTravel: LowResponsibilities:In support of the PCC system users, the Business Applications Manager - PV & Quality Applications will:· Work with PV, Quality and business users to define user requirements, functional requirements and technical specifications, and obtain business sign-off· Lead implementation, upgrade, enhancement, integration and support of PV and Quality applications including Argus, Ennov, Axway and other relevant GxP/non-GxP applications· Manage IT project teams and external vendors during rollout of IT projects, system upgrades, enhancements and support transitions· Maintain partnership with PV, Quality, Mfg.site and global IT teams, and act as IT SPOC for Quality applications within the team· Work with business users to review proposed design solutions and determine if the solution meets business, compliance and operational needs· Transfer knowledge to IT Support Team, manage change requests and ensure smooth handover of application support activities· Communicate and coordinate system changes with impacted business areas for smooth transition, implementation, validation and rollout of projects· Onboard vendors and manage external vendor teams to support ongoing PV, Quality, integration and business application needs· Support IT budget inputs for OPEX and CAPEX in accordance with internal procedures, ensuring best value, quality and continuity· Ensure customer satisfaction, build ongoing stakeholder relationships, manage expectations and provide timely project/support updates· Develop a deep understanding of PCC’s application landscape, software development approach, validation lifecycle and PV/Quality processes· Collaborate with Corporate/Central IT teams including IT Security, Infrastructure, SAP, Validation/CSV, Quality IT and other cross-functional teams· Collaborate with PCC IT teams to roll out PCC-specific applications, integrations, upgrades and process improvements across applicable sites· Work with technical teams to ensure interfaces, integrations, data migrations, access management and application changes are properly tested and documented· Support regulatory audits, CSV activities, audit responses, DI assessments, risk identification, CAPAs and monthly project/application status updatesEducation/Experience Required:B.S. in Information Technology, Computer Science, Engineering, Life Sciences or equivalent8-10 years of relevant experience in IT Project Management, IT Support Delivery, Business Applications or Enterprise Application ManagementExperience in Pharmaceutical, Life Sciences, Pharmacovigilance, Quality or Medical Device environment requiredExperience working on PV, Quality, ERP and integration applications; Argus, Ennov, Axway or SAP experience preferredExperience in application lifecycle management, business process support and stakeholder coordination across global sitesShould have past experience working and supporting IT systems used in regulated pharmaceutical operationsStrong understanding of computer system validation lifecycle, GAMP 5, GxP systems, data integrity and change control processesStrong Project Management experience; PMP, Agile, ITIL or other advanced certification preferredFamiliarity with project management tools, ticketing systems and office tools such as Word, Excel, PowerPoint and collaboration platformsExperience managing internal teams and external vendors, with excellent team-working skills in a culturally diverse environmentExperience working with global stakeholders including business, Quality, PV, IT, CSV, Infrastructure and vendor teamsTraining experience to assist system users to troubleshoot issues; ability to prepare training materials and lead training sessionsAbility to develop business cases, technology roadmaps and improvement proposals to promote new technologies and business outcomesCore Competencies Required:Positive attitude with excellent interpersonal and communication skills (written, verbal, presentation)Self-motivated individual who can excel with little supervision and the proven ability to be successful in a fast paced, dynamic environmentExcellent presentation, stakeholder management and cross-functional communication skillsAbility to effectively communicate business needs to technology teams and vendorsStrong service focus with a proactive customer service attitude and ownership mindset for business-critical applicationsAbility to lead teams, work collaboratively across geographies and drive results in a compliant and audit-ready manner