This position will 1). Plan and conduct internal and external quality audits, 2). Complete deviations related to Supplier defects, 3). Develop, implement and execute quality assurance systems related to supplier quality, 4). Complete corrective actions associated with systems, audits and deviations, and 5). Write and gain approval for Quality Agreements. This person will be required to travel to supplier locations.
- 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.
- Provide compliance guidance and support throughout the Quality and Compliance organization, and participate in multi-departmental teams and initiatives.
- Schedule, conduct and report on internal and external foreign and domestic audit activities of a complex nature.
- Assist in the planning and strategy of long term audit programs and department activities, such as internal facility training, internal site visits and participate on various company-wide teams and projects.
- Review and audit internal and external quality systems.
- 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.
- 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.
- Provide quality guidance and support to Operations functions by assessing, troubleshooting and recommending solutions to resolve compliance issues.
- Contribute to various company-side harmonization efforts, e.g. supplier management, audit tracking modules, and training modules/programs.
- 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.
- Stay current with Regulatory and Industry compliance trends and adopt auditing strategies as appropriate.
- Participate in intercompany working groups.
Manage and maintain all databases/tracking mechanisms for the Supplier Qualification and Management Program, as well as the Argos Quality System requirements.
- Bachelor’s degree/MS in a scientific or engineering discipline or equivalent expertise and training.
- Minimum of 5 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. GCP experience is a plus.
- Robust knowledge of pharmaceutical regulatory requirements, including relevant guidance, regulations and compendia (e.g. FDA, GMP, GLP, EMA, 21CFR 210 and 211, 21 CFR Part 11, and International Standards, ICH 8, 9, 10, USP/EP/JP Compendia, and ISO 9001).
- Excellent problem-solving skills, and 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/excellent technical writing skills, with the ability to independently develop and document various quality reports, audit reports, complex investigations, Quality Agreements and procedures.
- Demonstrated ability to explain complex deviations/production discrepancies 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, working well as part of a team and conflict management.
- Excellent project management and negotiation skills.
- Detail oriented with proven organizational skills.
- Ability/willingness to travel as required (at least 50-75% of the time).