RLT Remediation QC Specialist
57 East Willow Street Millburn NJ USA 07041 Millburn, NJ 07041 US
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.
Responsibilities include but not are limited to: Execute and/or review deliverables for the Site Remediation Project Plan, enabling overall strategic implementation of remediation activities according to the sites commitments to Health Authorities. Remediation activities are related to facility, equipment, quality systems, computerized systems, laboratory or products. Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership. Certified investigator for deviations and OOS; drive and/or review deviations and lead strategic discussion for investigations with respect to Quality Control related matters in support of record backlog reduction. Responsible for the design and implementation of corrective and preventative actions. Authors SOPs, work plans, method transfer/qualification/validation protocols, and reports according to Global Standards Define and plan agendas, deliver content and/or lead preparation for project governance meetings, as delegated by the Site Remediation Lead Responsible for routine reporting of the status of deliverables and risk to the Site Remediation Lead and delivering relevant content for governance meetings Reinforce the sites Inspection Readiness program for regulatory inspections, baseline audits /audits and providing hands-on support at sites in preparing for inspections / audits 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, control project scope to limit schedule changes, and capture changes of scope that may arise Partner with Site QC to ensure the Primary SME is trained and ready to deliver remediation evidence during regulatory inspections; final project handover, including Remediation Continuity Plan as needed
Key performance indicators:
- Successful and timely completion of the sites Remediation Plan deliverables, meeting strategic objectives of Global Remediation Task Force
- Successful Health Authority Inspections
Number of associates: N/A; indirect coordination with Global Remediation Task Force and multiple cross-functional stakeholders
Financial responsibility: (Budget, cost, sales, etc.) Adhere to established budget and costs
Impact on the organization:
High; significantly contributes to success of 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).
- B.S. degree in Science, Engineering or related field with 5 years relevant experience or MSc with 3 years of relevant experience.
- Experience in quality-based roles including experience in cGMP and/or laboratory operations required
- Must have a working knowledge of FDA and global regulatory requirements as well as industry quality management tools, standards, and quality systems.
- Must understand pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
- Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections
- Good understanding of local/National Health Authorities regulations and standards
- Excellent technical writing skills
- Demonstrated ability to problem solve and mediate complex issues. Project management capabilities preferred.
- Strong communication, leadership and team working skills
- Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously
- Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
- 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
- Highly motivated, driven and have a passion to be part of a fast-paced team
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.