Immunomedics, Inc. Morris Plains , NJ 07950
This position will be responsible for building and leading the technology function for the CMC (CTO office), QA , Finance and HR including responsibility for the technology enablement of its related solutions portfolio.
This position will work in close partnership with the CTO, QA and Finance leadership to define, implement and support the IT strategy and its execution. Act as a trusted advisor and consultant to business leaders balanced with ability to execute to deliver business outcomes.
This position will also be responsible for design, implementation, and enablement of the ERP capabilities to ensure core ERP processes related to finance, HR, manufacturing, supply chain, procurement.
This individual will provide leadership (direct and indirect) to the resources needed to deliver on the core capabilities encompassed within ERP including providing real-time intelligence, visibility, analytics, and efficiency across every aspect our data driven business. This individual will help drive proper information management practices enabled by integrated ERP systems and processes.
The successful candidate will bring significant prior experience in both leadership and execution roles of defining and delivering IT solutions for CMC, Manufacturing and Quality in the biopharma industry This position will lead a small team of professionals and vendor partners to build and manage the CMC & QA IT and ERP application roadmap and portfolio.
Creates and maintains the CMC, Manufacturing, QA and ERP IT strategy and roadmap and drives business value realization
Lead and manage the business analysis, roadmap development and guide all product activities for the ERP product portfolio
Lead Strategic Business-IT council to drive governance and PMO for the technology strategy and roadmaps for Mfg, QA, HR and Finance business units.
Accountable for delivering the technology solutions need to support the CMC, Manufacturing, QA and ERP business strategy and deliverables and managing the related portfolio over its entire life-cycle.
Build project plans, engage resources, and drive implementation projects to successful completion, meeting well defined requirements, managing scope, and keeping within project schedules and budgets;
Drives Portfolio Financial Management, managing the IT Portfolio Budget, aggregates strategic initiative financials, delivery performance, risk and issue reporting.
Collaborate with the Regulated Systems Support and IT Compliance group and Quality Systems Compliance, using risk-based approaches to validate GxP computerized systems.
Working with a mix of internal staff, contractors, managed services providers, and vendor resources, ensure successful delivery of technology support across the application portfolios
Manages an organization between direct reports, consultants, contractors and managed services of partner vendors of approximate 10 to 20.
Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.
Strong business acumen and technical knowledge regarding CMC, Manufacturing, Supply Chain, Quality Laboratories Supply Chain, and QA business area.
Strong knowledge and experience in ERP from design, implementation and operations in regulated industry (GMP)
Superior communication and listening skills with people at all levels of the organization.
Ability to promote an accountable and collaborative team-based environment.
Ability to articulate vision, strategy and related execution
Must be able to clearly explain concepts and value of project portfolios.
Strong and proven influencing, persuasion and negotiation skills.
Strong leadership skills to influence stakeholders and promote business value realization
Ability to build and maintain strong collaborative relationships with managers across the business.
Ability to effectively manage multiple simultaneous projects and deliverables in a cross-functional environment.
Ability to quickly adapt to changing priorities, assignments and roles.
Ability to drive change by understanding the importance of change management and the critical role that communications and training
Bachelors in Computer Science, Information Technology or an engineering majorwith prior experience working at a pharmaceutical/biotechnology company. MBA or other relevant graduate degree is a plus.
Minimum of 15 years of experience in Information Technology arena with at least 10 years management and strategic experience including in support of CMC, Manufacturing and QA business functions
Minimum of 8 years of experience with ERP implementations in a heavily regulated, compliance-driven enterprise environment, including GMP, and a strong track record of delivering complex projects across multiple departments. Experience in Tier-1 SAP or Oracle, as well as Microsoft GP and Dynamics strongly desired.Experience in financial management and budget planning as well as contract negotiation, vendor management including controls and service levels
Prior experience building and leading teams who tackle complex problems and perform broad technology implementations enabling the achievement of business goals
Experience managing multiple projects, including partnerships with external technology partners, simultaneously from design, deployment and operations.
Ability to manage competing demands in a fast-paced, dynamic environment where collaboration, communication, prioritization, and flexibility are key attributes for success
Advanced communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management.
Previous practical experience executing validation projects for GxP systems, including conducting risk assessments, designing validation strategy, and authoring validation deliverables.
Demonstrated ability to manage manufacturing plant IT operations and Quality laboratory systems operation is required.
Subject matter expertise in the Mfg. and QA Pharmaceutical/Biotech business