The Quality and Compliance Specialist 1). Executes all aspects of the Quality Agreement program, including maintenance of internal tracking databases of Quality Agreement implementation and revision due dates, ensures proper retention of approved Quality Agreement documentation, authors Quality Agreements and collaborates with internal Argos personnel and suppliers to finalize Quality Agreement documentation, 2). Participates in internal and external Quality Audits, as required and 3). Completes supplier-related deviations and CAPAs, as required.
- Implement and maintain all required procedures governing the Quality Agreement program and ensure updates are executed and implemented, as required.
- Establish and maintain databases and tracking mechanisms necessary to maintain complete listing of executed/approved Quality Agreements, Quality Agreements pending completion and the status of Quality Agreements requiring updating and approval.
- Remain current on regulatory requirements for the completion of Quality Agreements with suppliers and service providers and ensure procedures are updated as required.
- Ensure applicable personnel are trained on the procedural requirements to develop, execute and maintain Quality Agreements.
- Collaborate and negotiate Quality Agreement content with internal and supplier personnel. Ensure alignment of applicable personnel at Argos on Quality Agreement content.
- Author Quality Agreements, route for approval and ensure approval signatures are achieved on time.
- Monitor supplier performance and supplier audit results, identifying any discrepancies in adherence to Quality Agreement content. Notify appropriate Argos management personnel of discrepancies or negative performance trends for re-mediation.
- Perform all aspects of routine, initial and follow-up audits, including internal quality systems audits and external audits to support the GxP compliance and inspection readiness of Argos GxP systems, as well as the Supplier Qualification and Management Program, as required.
- Responsible/accountable for the on-time completion of and accuracy/robustness of Deviations, CAPAs, Internal Audits, External Audits and assignments.
- Lead and contribute to the development and execution of all inspection readiness activities.
- Prepare quality trending reports for oversight and annual quality reports.
- Efficiently and effectively partner cross-functionally with Manufacturing Operations, Clinical Operations, Quality Assurance, Quality Control, Regulatory, Research and Development, Manufacturing Science & Development and others as required to ensure cGxP compliance.
- Help to meet or exceed established timelines for all Quality deliverables.
- Bachelor’s degree in a scientific or engineering discipline or equivalent expertise and training.
- Minimum of 5 years of experience, with a minimum of 3 years within Quality Assurance/compliance in the pharmaceutical or biotechnology industry, including areas of responsibility requiring authoring of technical, investigative and/or Quality Agreement documentation.
- Knowledge of pharmaceutical regulatory requirements, including relevant guidance, regulations and compendia (e.g. FDA, EMA, ICH, USP).
- Proficient in tracking of data, analysis of performance data, and identification and implementation of corrective and preventive actions.
- Knowledge of Quality System requirements and the ability to identify improvements to systems and procedures.
- Demonstrated ability to appropriately manage confidential information and adhere to confidentiality and Quality Agreement requirements.
- Demonstrated ability to write investigations and Quality Agreements.
- Demonstrated ability to explain deviations and GMP systems/processes internally, as well as with external sources (such as Suppliers, Service Providers and Auditors/Inspectors).
- Self-motivated problem solver with strong collaboration skills, who takes initiative, effectively manages complexity and resourcefully resolves ambiguity.
- Clear written and verbal communication skills and sound interpersonal skills including collaboration and conflict management.
- Excellent project management, negotiation and organizational skills.
- Ability/willingness to travel as required (approximately 25%).