The Manager holds responsibility within the DSQ organization in the area of Quality Operations including CAPA management, essential document reviews, process improvement projects, metrics analysis and reporting, and inspection readiness/response. The Manager demonstrates a significant amount of subject matter expertise in regulations and GxPs, as well as strong core competencies in organization, planning and communication. The Manager may be offered opportunities to take on lead roles in key internal initiatives, take on a study team representation role, and manage other staff.
Identify, investigate and manage quality issues or events that arise within DevSci functions, studies or project teams; provide guidance on resolution and facilitate appropriate escalation to DSQ management
Collaborate with teams and functional areas and oversee the documentation, investigation, and resolution of all DevSci SOP deviations
Verify the appropriate closure of all protocol deviations and related CAPAs; analyze protocol deviation trends and communicate findings and impacts to affected DevSci functional areas or study teams
Review and perform effectiveness checks on all closed CAPAs as a result of DevSci SOP and protocol deviations
Oversee the management of updates to DevSci Trackwise based on user requirements
Quality Guidance on Essential Study Documents and Regulatory Submission Documents
Conduct risk based reviews and provide guidance on essential regulatory required documents including, but not limited to, clinical protocols, investigator’ s brochures, case report forms (CRFs), informed consents, monitoring and data management plans for GCP compliance and inspection readiness
Perform risk based quality assessments of processes and procedures, as assigned, and communicate findings to respective DevSci functional stakeholders and DevSci Management
Quality Process Improvement
Lead or participate in the execution of DevSci Quality process improvement projects across the DevSci organization verifying that fit for purpose quality practices are implemented throughout functional areas within DevSci
Maintain ongoing awareness of industry and organization-wide best practices for quality and share information across DSQ and DevSci as necessary.
Identify and assess opportunities to develop and improve key elements of the DevSci Quality Management System.
Support efforts to collaborate with Compliance on understanding of requirements on any new regulatory requirements; for any new regulations, conduct gap analyses of DevSci systems, processes, and supporting documentation, outline impact, define changes required, and support implementation to verify compliance.
Support the development, implementation and maintenance of a robust metric tracking and trending and related impact analysis process that provides risk based information to the DevSci organization.
Provide Study and Project teams with protocol deviation and trend analysis and verify performance trends are addressed and adjudicate
Inspection and Audit Response Management
Collaborate with Compliance to review and understand impact of all DevSci related Audit and Inspection findings
Support DevSci functional areas in understanding, interpreting and determining impact of Audit and Inspection finding
Verify adequacy of all DevSci Inspection and Audit responses by:
Leading coordination efforts among involved functions and providing status and needs communications
Supporting, facilitating and assessing adequacy of the development of Audit or Inspection response documentation
Oversee the creation of Quality Reviews/quality checks of essential regulatory required documents in preparation for Audits and Inspections.
Review, monitor, and perform quality checks on all Corrective and Preventive Action Plans (CAPAs) from Audits and Inspections to achieve timely closure.
REQUIREMENTS / QUALIFICATIONS:
BA/BS in life sciences or technical area; experience in lieu of education may be considered
6+ years of relevant pharmaceutical industry experience
1 or more years of people management experience
Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus