Commercial Quality Lead
6 month contract with extensions
Horsham, PA, Titusville, NJ, or Somerset, NJ
The overall purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, documentation, internal audit/ supplier audits. Adheres to environmental policy, procedures, and supports department environmental objectives.
Responsibilities:
- Process day-to-day product quality complaint (PQC) in TrackWise system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (25%)
- Create query and report of PQCs from TrackWise for all products and provide in-depth data analysis of complaint information and trending. Review medical information requests from database and provide in-depth data analysis (25%)
- Process day-to-day change control records in TrackWise system (10%)
- Coordinate documents and procedures in truVault system (15%)
- Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in TrackWise system. Ensure all audit commitments are delivered on time (25%)
Knowledge
- >=5 years’ experience in the Pharmaceutical or related industry;
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
- Experience working in the quality organization.
Skills
- Highly experienced in TrackWise system, generating query and report, and data analysis with excel spreadsheet
- Results-driven leader who commits to stretch goals and delivers results.
- Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial and Quality functional groups.
- Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and the organization more broadly. Experience in dealing with regulatory inspections and inspectional requirements
