RLT Site Remediation Lead in Millburn, NJ

RLT Site Remediation Lead

Location - Onsite role in Millburn, NJ

Summary

• Reporting to the Site Quality Head, the AAA Site Remediation Lead is responsible for executing remediation project plans at the site, ensuring successful completion of remediation commitments and successful inspection outcomes.
• This role is also responsible for coordinating the site’s routine remediation tactical meetings, reporting status and risk, and driving resource management, fulfilling Quality and Tech Ops remediation commitments and initiatives.
• This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level.

Major accountabilities:

• Responsibilities include but not are limited to:
• Right-hand person for the AAA Site Quality Head with respect to the site’s Remediation Plan
• Execute, monitor, and control Site Remediation Project Plan for overall strategic implementation of deliverables within the site’s commitments to Health Authorities.
• Manage a site-based team of resources responsible for the execution of remediation tasks relevant to the site’s remediation objectives.
• Work in close collaboration with the site’s Tech Ops and Quality associates, as well as AAA RLT Global Remediation Task Force Lead, AAA RLT Global Remediation Project Manager, and AAA global technical functions (i.e. Global Engineering, Global QC, Global Sterility Assurance) to harmonize remediation strategy and outcomes across the RLT platform.
• Responsible for routine reporting of the site based Remediation Plan status to appropriate stakeholders and delivering relevant content to Global Remediation Task Force and/or Remediation Steering Committee meetings, on behalf of the Site Quality Head.
• Drive the site’s Inspection Readiness program for regulatory inspections, internal audits and providing hands-on support at sites in preparing for inspections / audits
• Define and plan agendas, deliver content and/or lead preparation for key site-based remediation management engagements and governance meetings including, but not limited to, Site Remediation Tactical Meetings, project governance meetings, and other core Strategy team meetings.
• Leverage project tools and templates to ensure streamlined project management across the network and adherence to strategic remediation communications plan.
• Support Site Quality Head and Site Head with budget planning and maintenance by ensuring the most up to date project information is available. Responsible for monitoring and controlling remediation spend at the site.
• Identify and mitigate projects risks, including timely escalation to Local and Corporate management.
• Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.
• Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders. Control project scope to limit schedule changes and to capture changes of scope that may arise.
• Partner with Procurement to ensure smooth sourcing and delivery of services and/or assets required for remediation activities across the network.
• Perform provisional and final project handover, including Remediation Continuity Plan as needed

Key performance indicators:

• Successful execution of Site Remediation Plan, meeting strategic objectives of AAA Global Remediation Task Force.
• Successful Health Authority Inspections Minimize business continuity risks.
• Feedback from internal and external partners.

Financial responsibility:

• (Budget, cost, sales, etc.)
• Adhere to established budget and costs

Impact on the organization:

• High; significantly contributes to success of AAA RLT objectives by ensuring cGMP-Compliance with focus on Successful Health Authority Inspections & correct, cGMP compliant decisions as part of critical Quality Issues (e.g. market actions).

Requirements:

• Graduate in Chemistry, Pharmacy, Microbiology or another related science and/or recognized formal project management qualification (PMP/APMP/Prince2/P30 or equivalent) desirable.
• Minimum of 3 years of experience in quality-based roles including experience in GMP and/or laboratory operations required
• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections is preferred.
• Good understanding of local/National Health Authorities regulations and standards
• Strong communication, leadership and team working skills
• Demonstrated negotiation and conflict resolution skills both internal and external (cross network relationships)
• Highly motivated, driven and have a passion to be part of a fast-paced team
• Effective in prioritizing, shows the appropriate sense of urgency around given tasks and driven to grow a business
• Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
• Strong analytical skills, problem solving ability and presentation required
• Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization – oral and written
• Demonstrated ability to work cross-functionally
• Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Languages: English fluently, verbally and in writing. Native language to where the site is based is favourable.

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