Quality Assurance Lead
Newark Metro Area, NJ
Develop tools and methods for the North American Quality Business Integrator Project Management Expert to integrate into the Commercial organization as a business partner to proactively identify, navigate, and drive risk discussion and avoidance.
1. Build tools to support the implementation framework of Business Integrator activities to develop strategic relationships with key Business Unit (BU) personnel to collect insights and foster a quality culture.
2. Document workflow of effective approaches to foster collaboration with BUs to address activities which are relevant to Quality or Inspection Readiness, communicated objectively, and translate ideas into functional plans.
3. Create a playbook for stakeholder identification, relationship development, and engagement
4. Identify methodologies to collect insights, and establish a defined risk assessment process to prioritize critical quality or business risks. Implement a tracking tool to ensure escalated activities and drive action plans to completion.
5. Develop metrics, dashboards, presentations supporting communication of action plans, milestones, and timelines to key stakeholders and co-sponsors.
6. Develop risk review process and tracking methodology to provide the organizational line of sight to the identification and prioritization of trends, risks and support the strategic development and execution of risk mitigation plans. Support liaise with NAQ teams to ensure awareness of BU priorities, actions, and escalation of areas of concern.
7. Establish Business Integrator OPIs and KPIs to ensure objectives are defined and measureable.
8. Collect data from key stakeholders to compile the ongoing review and reporting of the Affiliate Quality Report and Internal Control Manual and other controls reviews including ensuring that identified gaps are addressed and closed by required milestones for all relevant areas. Prepare presentations for delivery to leadership councils to align on objectives and deliverables.
9. Supports the Quality Performance Indicator analysis process to ensure proper reporting and identify areas of improvement and working with relevant partners manage projects to address process improvement opportunities and ensure inspection readiness.
10. Stakeholder engagement/Business Integration: Partnership with business areas, embrace GxP and HRA business processes and correlate to development of winning strategies for NAQ and/or risk mitigation
11. Support Quality reporting activities: Champion the creation and implementation of technical solutions and strategize continual process improvements and business engagement activities as necessary (e.g. Proven Industry CI tools)
12. Implement a dashboard for leading Quality indicators for proactive communication of Event, Deviation, CAPA and Change Management trends
A higher-level resource who is qualified and experienced in enterprise risk tolerance, Commercial business acumen, relationship-building and negotiating prowess, while being a seasoned Quality-minded professional.
Strong planning, tracking, and follow-up skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
A strong working knowledge of business processes, including strategic planning and budgeting, is highly desirable.
Candidate must possess exceptional communication skills, both oral and written, excellent organizational time management skills, and the ability to collaborate and align with diverse, cross-functional matrix teams.
Candidate must have experience with Excel and analytics. Experience with Risk management tools preferred.
Education: Minimum 10-20 years of experience in pharmaceuticals/life science, adept in Quality and commercial business acumen with concentration in stakeholder engagement, mediation, negotiation, and risk profile assessments.
Project Management Certification a Plus