Sr. Mgr, IT Project Management - Gxp

PTC Therapeutics South Plainfield , NJ 07080

Posted 2 months ago

Job Description:Summary:

The Sr. Mgr, IT Project Management

  • GxP is responsible for providing project management leadership for the development and implementation of IT solutions addressing PTC's business requirements. This position serves as a liaison between business end-users and technology professionals / resources. The PM collaborates closely with the business to: develop detailed project timelines and project plans, translate existing or new business needs into detailed functional requirements, analyze business gaps and opportunities, prepare technical specification documentation, and develop / implement scalable, quality solutions. The PM collaborates closely with quality to: determine quality deliverables required as per Health Authority Agencies (FDA, EMEA, etc.), adherence with current local and global regulations and laws and to follow current PTC processes and procedures.

The incumbent works cross-functionally with internal departments and external resources on Project Management-related issues.

The Sr. Mgr, IT Project Management

  • GxP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

  • Leads cross-functional project teams and works with business process owners to determine and translate business requirements into technology solutions. This includes responsibility for planning, directing and coordinating projects from initiation through to implementation.

  • Engages with business process owner, business stakeholders, and internal / external IT delivery team members to define and document business processes / needs, identify appropriate solutions and develop detailed roadmaps and project timelines / plans. This includes the development / oversight of the project budget and the definition of project deliverables.

  • Coordinates communication within the project team, escalates and facilitates the resolution of risks, issues, and changes.

  • Effectively interfaces and communicates with senior management and all key stakeholders regarding project deliverables, project status, risk identification / mitigation, issue management and budget spend.

  • Oversees all phases of solution implementation and the corresponding project and quality documentation to ensure adherence to budget, schedule and scope.

  • Provides on-going project management support to plan, prioritize and deliver system enhancements.

  • Develops high-level and detailed project plans and ensures that the scope and approach are fully understood by all stakeholders.

  • Actively manages project costs, resources, change requests, risk and issues to ensure maximum business benefit.

  • Knowledge of Project Management Institute (PMI) methodology and best practices for project management to help develop standards, processes around project management, prioritization, and portfolio management.

  • Functions as a liaison between the business, quality and IT for those business units they have been assigned to manage projects, and other organizations / teams / functions throughout the business. This includes helping build strategy, functionality, acting as an SME, and helping to escalate issues to IT Service Management and the IT Service Desk.

  • Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

  • Minimum level of education and years of relevant work experience.

  • Bachelor's degree in a related discipline and a minimum of 7 years of progressively responsible experience in related roles (including a minimum of 4 years of demonstrated IT project management experience) in a pharmaceutical, biotechnology or related environment with a focus on GxP system implementations.

  • Special knowledge or skills needed and/or licenses or certificates required.

  • Project Management Professional (PMP) Certification preferred but not required.

  • Direct and demonstrated IT project management experience including experience leading large, complex, enterprise-wide, transformative projects.

  • Demonstrated experience leading the identification, development and implementation of GxP validated systems.

  • Experience identifying, developing, customizing and implementing vendor software, particularly Software As A Service (SaaS).

  • Hands-on experience with one or more of the following: Research and Development (R&D) technologies, Document Management Systems (DMS), Quality Management Systems (QMS), electronical Trial Master File (eTMF), Enterprise Resource planning (ERP), and Customer Relationship Management (CRM).

  • Proficiency with PPM Solutions.

  • Proficiency with Microsoft Office (including applied experience using MS Project).

  • Excellent verbal and written communication and skills.

  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

  • Special knowledge or skills and/or licenses or certificates preferred.

  • Advanced (MS/MA) degree

  • Experience with Clarity PPM

  • Experience with Veeva Vault applications

  • ITIL Foundations Certification

  • Travel requirements

  • 0- 5%

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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Sr. Mgr, IT Project Management - Gxp

PTC Therapeutics