Supports Senior Management in maintaining robust quality systems and assuring regulatory compliance within Clinical Pharmacology (CPS), Clinical Data Analysis and Reporting Organization (CDARO) and Early Clinical Development (ECD).
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 efficiently with staff members of other functional groups to resolve issues. Represents the company in preparation for and hosting of regulatory inspections and client audits, as needed. Inspects studies, audits protocols, data and reports in compliance with appropriate SOPs, GCPs,
GLPs, and cGMPs (includes auditing of data, reports and phases for protocol compliance) in multiple disciplines. Initiates and facilitates quality improvement objectives throughout the organization. Performs external audits of service providers. Represents the company in direct interactions with client auditors and Health Authority investigators. 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 when requested.
♦ Act as an expert on broad based routine (day-to-day) regulatory compliance issues, and provide
guidance to teams in areas of regulatory compliance.
♦ Interprets GCPs, applicable GLPs, and cGMPs 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 inspection 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.
♦ Ensures through process and data inspections that the SOPs, which are involved in the conduct
of a study, are current and practiced.
♦ Identifies and communicates opportunities for process improvement based on audit and
inspection observations. Participates in and guides process improvement activities in both
Educated to Degree level, or equivalent in a scientific or nursing discipline or equivalent industry experience.
Demonstrated competencies in quality assurance practices and regulatory compliance knowledge.
Proficient in use of computer and Microsoft software programs (e.g., Word and Excel)
Ability to effectively interact with staff. Ability to independently negotiate, provide constructive feedback and support process improvement initiatives.
Skilled in both verbal and written communication to effectively communicate and negotiate.Experience:
Minimum of 5 (five) years' experience in the pharmaceutical/CRO industries, with at least 1 (one) year in Clinical Quality Assurance, preferably within a GCP environment.
Additional experience may be substituted for educational requirements.
Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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