Manager – Business Application

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Division

Piramal Critical Care

Piramal 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 Title

Manager – Business Application

Job Description

The 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 Care

Department: Information Technology

Location: Kurla, Mumbai

Travel: Low

Responsibilities: 

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 updates

Education/Experience Required:

• B.S. in Information Technology, Computer Science, Engineering, Life Sciences or equivalent
• 8-10 years of relevant experience in IT Project Management, IT Support Delivery, Business Applications or Enterprise Application Management
• Experience in Pharmaceutical, Life Sciences, Pharmacovigilance, Quality or Medical Device environment required
• Experience working on PV, Quality, ERP and integration applications; Argus, Ennov, Axway or SAP experience preferred
• Experience in application lifecycle management, business process support and stakeholder coordination across global sites
• Should have past experience working and supporting IT systems used in regulated pharmaceutical operations
• Strong understanding of computer system validation lifecycle, GAMP 5, GxP systems, data integrity and change control processes
• Strong Project Management experience; PMP, Agile, ITIL or other advanced certification preferred
• Familiarity with project management tools, ticketing systems and office tools such as Word, Excel, PowerPoint and collaboration platforms
• Experience managing internal teams and external vendors, with excellent team-working skills in a culturally diverse environment
• Experience working with global stakeholders including business, Quality, PV, IT, CSV, Infrastructure and vendor teams
• Training experience to assist system users to troubleshoot issues; ability to prepare training materials and lead training sessions
• Ability to develop business cases, technology roadmaps and improvement proposals to promote new technologies and business outcomes

Core 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 environment
• Excellent presentation, stakeholder management and cross-functional communication skills
• Ability to effectively communicate business needs to technology teams and vendors
• Strong service focus with a proactive customer service attitude and ownership mindset for business-critical applications
• Ability to lead teams, work collaboratively across geographies and drive results in a compliant and audit-ready manner