The Quality Assurance Compliance department provides strategic leadership, direction, and oversight for the related Allston Quality System and is responsible for assuring site inspection readiness in alignment with Corporate Standards, global good manufacturing practices, regulatory requirements/guidance and current industry best practices. The department provides oversight for the identification of risk, escalation of risk, monitoring of corrective actions and audit/inspection commitments. The Quality Assurance Compliance department makes decisions and conducts activities in Quality within constraints imposed by broad company policy and government regulations.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. The Quality Auditor Senior schedules and conducts internal and vendor audits as well as producing reports and conducting follow-up to non-compliance issues, requiring the ability to lead and coordinate diverse audit teams
Managing external inspections by regulatory agencies and Global Quality Auditing, including response management and tracking of commitments, site Internal Audit program, Quality System Champion responsibilities, Site Quality Council Governance, Quality Notification and Escalation, Site Risk Profile, Global Response Team for the site (GRT audit and Regulatory Intelligence), Supplier Management Program (Supplier Management Team and QTA), and ensuring the Quality System remains aligned with corporate standards, directives and procedures.
Conducts self-audits/inspections, which may include GxP and/or ISO compliance evaluations, by interpreting and applying complex, exact documentation of regulatory and corporate procedures, as well as industry best practices and regulatory enforcement trends/actions.
Supports timely development and closure of internal and external audit responses and CAPAs
Assists in guiding and advising on regulatory and corporate GMP compliance topics with Manufacturing, Facilities, Quality Control, R&D/MSAT and Quality Assurance. Participates in the development of corporate quality and compliance policies, and conduct training of site personnel.
Coordinates the review, deployment, gap analysis, and implementation activities for the Corporate Quality Standards and Directives, Global Operating Procedures and Practice documents, including monitoring progress with status reports and metrics. Contributes to the Regulatory Intelligence communication process, and Global Response Team site responses
Participates in support functions to ensure successful external agency inspections
The Quality Auditor may also support the Specialty Care Massachusetts SMT (Supplier Management Team) providing site-level Quality oversight to Supplier Lifecycle Management by reviewing and approving Requests for new material and services, Supplier Change Notifications (SCNs), Supplier and Service Corrective Actions (SCARS) and Supplier Audit Reports
Ability to lead and manage the internal audit life-cycle (planning, execution, reporting, managing response, follow-up on commitments/CAPA)
Participation in internal/vendor audits as SME/Co-lead/Lead
Received auditor training or certification (American Society for Quality (ASQ) Certified Auditor or equivalent)
Knowledge in external agency regulations Experience determining compliance trends
Ability to advise, coach auditees Proficiency in Microsoft Office
Familiarity with Trackwise or equivalent system Experience with project management
Strong communication, initiative, collaboration skills and attention to detail. Excellent communication skills, good presentation and influencing skills with the ability to interact and gain the support of management
Demonstrated experience in continuous improvement initiatives, partnering with other departments (internal and external to the site) for enhanced inspection readiness Skilled in achieving results toward corporate, site, and departmental objectives.