Quality Project Lead
Temp-to-Hire - Ft Collins, CO or Richmond, VA
The Quality Project Lead is a critical part of the global Quality and Supply organisation, supporting and working in partnership with the operational quality and supply teams, quality systems team and other GxP functions.
The position is a hands-on role providing support, documentation, execution and reporting of the Global Quality System records. Responsibilities include, but are not limited to, the generation and review of quality records, reporting and escalation of potential issues with progress of quality records, and participation in various quality and business operational forums where their input is required.
The position will also include the coordination of Quality Operations’ projects and ensuring timelines are tracked, communicated, and held to agreed timelines.
The responsibilities of this job include, but are not limited to, the following:
- Key person in the administration of the global Pharmaceutical Quality System (PQS). Showing status and health of the PQS.
- Work across functional boundaries to ensure alignment of quality system standards and helping to drive continuous improvement of the PQS.
- Drives Quality projects within and across functions and with external partners to meet regulatory and internal commitments.
- Initiate and manage Change Control records in TrackWise on behalf of the Quality Operations and Supply function.
- Operate as ‘Assignee’ of the quality event records and push records through the workflow on behalf of the change control owner.
- Contribute to the standardisation of change control, along with deviation, and CAPA records through working with the Process Owners other key quality and compliance roles in different GxP functions.
- Ability to work in project teams and extract the relevant information needed to complete change control records.
- Coordinate input and supporting documents for quality records from the owners.
- Obtain and load evidences for record closure.
- Ensure timely management of records owned by Quality Operations globally.
- Monitor and chase overdue change control, deviation and CAPA records, approvals, and closure of actions cross-functionally.
- Understand what fields need to be populated for complete quality records, successful queries, and reporting.
- Expert who understands the TrackWise workflow.
- Help users monitor and progress-controlled document records through workflows including training configuration in iLearn and setting of effective dates and document withdrawals in the electronic document management system (D2).
- Monitor and chase overdue and periodic review of Controlled Procedural Document updates cross-functionally.
- Provide support to document owners to upload documents and push through revision and approval workflows.
- Organize and manage multiple records, projects and tasks with accuracy while maintaining a vision of the result.
- Author and improve Quality processes and procedures.
- Bachelor of Science degree in a life science or engineering discipline is desirable.
- Knowledge of the pharmaceutical industry and Quality Systems or experience within a GxP discipline (GPV, GCLP, GMP, GDP) required
- Proficient at assessing the impact of change on the quality organization and ability to work cross functionally to implement change plans.
- Knowledge of regulatory requirements for drug products including FDA, EMEA, Health Canada and other markets.
- Experience in manufacturing and laboratory analysis of pharmaceutical drug products is desirable.
In addition to the minimum qualifications, the employee will demonstrate:
- Ability to work in a team and cross-functionally when required.
- Good communication skills, both written and oral.
- Developing influential skills in areas with no direct reporting authority.
- Ability to work independently to deliver outputs and through others as required.
- Attention to detail.
- Adept IT skills and ability to learn quickly.
- Proficient in English. However, fluency in other languages is advantageous.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.