Supports Senior Management in maintaining robust quality systems and assure regulatory compliance within Clinical Pharmacology (CPS). Proactively drives improvement in the Quality Assurance (QA) organization as well as in the Operations practices. Provides interpretation of external requirements and develops practical solutions to attain full compliance. Interacts independently with staff members of other functional groups and senior management to resolve issues.
Represents the company in preparation for and hosting of regulatory inspections and client audits, as needed. Represents the company in direct interactions with client auditors and Health Authority investigators. Audits studies, protocols, data and reports in compliance with appropriate SOPs, and GCP requirements,. Initiates and facilitates quality improvement objectives throughout the organization. Performs external audits of service providers. Mentors less experienced staff.
Duties and Responsibilities:
- Hosts client audits and interacts with Health Authority inspectors to represent the company.
- Coordinates preparations for, and participates in regulatory inspections.
- Act as an expert on broad based routine (day-to-day) regulatory compliance issues, and provide leadership to teams in areas of regulatory compliance.
- Interprets GCPs and associated regulatory documents to facilitate auditing and process improvement recommendations.
- Audits protocols, phases of clinical studies, reports, and performs related duties (e.g. schedules studied/inspections, issues QA statements) to ensure regulatory compliance.
- Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Data Services, IRB, Archives, Vendor and Facility Audits).
- Writes and issues audit reports. Works with internal customers to ensure that inspection findings are clearly communicated and understood. Evaluates inspection-finding responses to ensure they are written to address the findings appropriately.
- Identifies and communicates, with little or no supervision, opportunities for process improvement. Participates in and guides process improvement activities in both small intradepartmental group as well as complex and possible multi-departmental interactions.
- Is able to present in small group training on specific GCP topics.
- Mentors less experienced auditors.
- Notifies management of observed quality and compliance trends.
- Schedules and coordinates work with study project teams and supervisor/peers in Quality Assurance.
- Special Projects
- Lead/participate in QA projects
- Supports special projects requiring QA input
- QA Global Lead /Representation
- Represent QA on Project teams, management meetings, and other internal forums
- Represent QA at client meetings and/or their third party auditors
- Represent QA with specific clients as assigned
- Interact independently with client representative(s) as applicable
- Track & ensure resolution to client issues as applicable
- Inform management of client concerns as applicable.
- Meet all timelines established with client representative(s) to assure superior client service
- Direct and regular communication with the Covance lead contact(s) for preferred partner relationships
- Performs other related duties as assigned.