The Senior Quality and Compliance Specialist drives and executes the development, implementation, execution and improvement of systems and procedures required to ensure regulatory compliance and permanent inspection readiness for internal GMP Systems, as well as the Supplier Qualification and Management Program.
- 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.
- Develop thorough internal and external audit plans for the oversight of Argos GMP/GLP systems and suppliers to maintain regulatory compliance with global regulatory requirements/guidelines.
- Collaborate with and oversee external suppliers/service providers to conduct audits, review/assess compliance status of contracted materials and services related to GMP manufacturing and laboratory testing activities.
- Perform routine and non-routine, initial and follow-up GxP audits for Argos internal GMP systems and external suppliers/service providers in support of PAI readiness, permanent inspection readiness and the Supplier Qualification and Management programs.
- Drive the process of responding to audit/inspection findings and develop appropriate CAPAs for internal processes within Argos, external suppliers/service providers and inspections by external regulatory agencies (e.g. FDA, EMA, etc.).
- Responsible and accountable for tracking and ensuring the timely delivery of all committed mitigation activities and deliverables to achieve regulatory standards.
- 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.
- Manage and maintain all databases/tracking mechanisms for the Supplier Qualification and Management Program, as well as the Argos Quality System requirements.
- Prepare quality trending reports for oversight and annual quality reports.
- Identify and ensure appropriate tracking of process improvement initiatives and initiate, consult, implement and provide training (in association with other relevant department representatives) on agreed upon process improvement initiatives.
- Review, develop and continually update Internal and External Auditing, Supplier Qualification and Management program and Quality-related procedures (in association with relevant department colleagues) in support of compliance requirements and continuous improvement.
- Organize, lead and participate in internal and external audits, including completion of all documentation requirements (audit checklists, reports and written/verbal communication).
- Execute all aspects of the Quality Agreement program, including collaboration and negotiation of Quality Agreement content, writing of Agreements, timely updating of documentation and maintenance of internal tracking databases and reports.
- Lead resolution on supplier-related material discrepancies/deviations to ensure timely release, hold or rejection of materials.
- 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.
- Develop and provide training to colleagues as required, as well as ensure timely completion of all required training.
- 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 7 years of experience, with a minimum of 5 years within Quality Assurance/compliance in the pharmaceutical or biotechnology industry, including hands-on experience with oversight of Quality System requirements and participation in internal and/or regulatory audits/inspections.
- Robust knowledge of pharmaceutical regulatory requirements, including relevant guidance, regulations and compendia (e.g. FDA, EMA, ICH, USP).
- Proficient in root cause analysis, including utilization of Six Sigma Root Cause Analysis tools and techniques.
- In-depth knowledge of Quality System requirements and the ability to identify improvements to systems and procedures.
- Demonstrated ability to write complex investigations and Quality Agreements.
- Demonstrated ability to explain complex deviations and GMP systems/processes internally, as well as with external sources (such as Suppliers, Service Providers and Auditors/Inspectors).
- Highly 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 (up to 25%).