Job details
Job type full-time contract number of hires for this role 6
Full job description
Job summary:
Execution and support of good laboratory practices (glp); good clinical practices (gcp), good pharmacovigilance practices (gpv), and good pharmacoepidemiology practices (gpp) quality programs; oversight of activities supporting pre-clinical and clinical development, medical affairs, pharmacovigilance and regulatory for client and all subsidiaries.
All activities are conducted in compliance with federal regulations and company standards.
Primary responsibilities:
Assure that pre-clinical, clinical and post marketing studies/programs are complete and meet internal and regulatory requirements:
Participate on project teams as the quality unit representative to assure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.
Review project timeline to ensure it accurately captures all quality activities.
In accordance with the project timeline, review and approve study plans and materials for compliance, and contracts/proposals to ensure they adequately capture qa requirements.
Support continuous improvement and remediation for areas identified by internal audit and ci team initiatives.
Serve as glp/gcp/gpv/gpp subject matter expert in support of internal and external study teams.
Develop/manage a comprehensive annual audit plan including internal customers, vendors, and clinical sites consistent with industry standards.
Support/perform assigned audits and follow up(this will require travel as appropriate).
Provide management with documented status and metrics monthly.
Ensure quality systems in client areas are effectively used to ensure compliance.
Drive deviations/investigations to appropriate and timely resolution with capa.
Perform qc and/or qa audits of documentation targeted for fda and/or other key external parties.
Work with client areas to maintain schedule of upcoming documents and agree appropriate review.
Support regulatory inspections and post inspection follow-up and corrective action implementation.
Remain current on regulatory expectations and best practices through constant monitoring of changes to regulations, guidance documents, and industry trends related clinical, safety and regulatory reporting.
Performs other related assignments and duties as required and assigned.
Education and experience:
Bs required and 6 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (ms preferred) with 4-6 years minimum relevant experience.
Necessary knowledge, skills, and abilities:
Current working knowledge within relevant technical discipline of fda regulations and awareness of the necessity and impact of compliance on the business including compliance systems and tools.
Effective interpersonal, verbal and listening skills.
Knowledge of and adherence to appropriate regulations are critical.
Demonstrated application and working understanding, knowledge, and ability in primary discipline.
Knowledge of gxp regulations in other disciplines and awareness of impact on cross-functional areas.
Interpretation of regulations and expertise in glp/gcp/gpv/gpp programs are the basis for corporate quality assurance in the pharmaceutical industry.
Detailed analysis of the code of federal regulations and ich requirements is combined with a common-sense approach to implementing the regulations.
A thorough understanding of programs and program specific contracts is required to assess the adequacy of project plans and study deliverables.
Strong and creative negotiations are required to achieve the highest level of quality while meeting time-driven and economic constraints.
The srQuality specialist:
Exercises good judgment in interpreting, understanding context and reporting data.
Effectively identifies, describes, and communicates problem and impact in a timely manner.
Routinely participates in problem resolution.
Identifies, tracks, and resolves issues to closure.
Proactively identifies potential problems and recommends possible solutions
Job types: full-time, contract
Schedule:
8 hour shift
Work remotely:
Temporarily due to covid-19
