Business Processes/ Change Management Consultant

MUST HAVES:

1) GXP environment experience required, PV experience preferred

2) Project mgmt., experience with proven ability to manage multiple projects at a time. PMP certification is a plus.

3) Ability to work on critical initiatives under pressure with attention to detail.

Job Summary

Collaborate with colleagues, customers, and stakeholders on projects relating to process enhancement and continuous improvement in the context of procedural documentation development for the NAO Patient Safety organization.

Job Responsibilities:

• Lead a team comprised of subject matter experts, business process owners, and key stakeholders, in the development, revision, process enhancements, implementation and maintenance of process and procedural documentation.
• Plan and manage process development projects.
• Apply knowledge and understanding of global regulations in a GxP environment and produce processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection ready and is designed with operational effectiveness in mind.
• Contribute to compliance and audit/inspection readiness strategies and plans.
• Evaluate global procedural documentation against evolving industry/regulatory requirements and expectations, audit/inspection findings, business needs, higher level corporate policies, changes in industry standards and client feedback and trends, and make recommendations for changes when necessary.

Qualifications:

• A minimum of a BA or BS is required, advanced degree in relevant field desirable. Degree or professional certification in process design or change management, or equivalent experience.
• A minimum 3 years experience in design and documentation of pharmaceutical business processes and change management required. Experience in process training development, delivery and/or implementation preferred.
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills.
• Ability to adapt to changing situations and work well under pressure.
• Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project).
• Strong verbal and written communication skills.
• In-depth understanding of pharmaceutical business processes (safety, regulatory, medical and/or clinical) and regulations, guidelines and industry standards for compliance.

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