Program Manager, Clinical Quality Assurance

Assure that R&D remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations. Assess the success and effectiveness of the R&D quality system and assure R&D's inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. PAI readiness assessments). Provide consultation and assistance to GPRD personnel on compliance issues. Assist management in conducting regulatory inspections including drafting responses to regulatory deficiencies. Provide R&D personnel with training on applicable worldwide regulations. Lead cross-functional project teams to help identify potential issues and resolve current issues. Manage compliance issues in Global Project Team/Functional Area programs, escalating issues to R&D QA management as appropriate. Directly coordinate internal and external compliance auditing programs for the R&D GCP organization.

Key Responsibilities Include:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Directly coordinate R&D GCP Compliance auditing programs.
• Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures. Supervise auditors responsible for the review of data, protocols and reports to assure quality and integrity of results.
• Plan, organize, and lead multiple audits of R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally. Coordinate and maintain audit schedules and ensure periodic updates and appropriate metrics are provided to management.
• Plan, organize and lead multiple audits of investigative clinical sites to assess compliance with regulations, guidelines, policies, procedures and sponsor requirements
• Review a variety of clinical research documents such as protocols and research reports to assess the quality and compliance to policies, procedures, and applicable governmental regulations
• Evaluate the potential risk of compliance deficiencies across protocols and/or compounds within assigned Therapeutic Area/Program, utilizing tools such as metrics and trending of audit findings, and communicate compliance risks to R&D QA management
• Identify services, maintain audit schedule, plan, organize and lead audits of external contract facilities (specialty testing laboratories, central laboratories, clinical sites, central Institutional Review Boards (IRBs), Contract Research Organizations (CRO) and distributors as applicable) both within the US and globally
• Communicate Contract Research Organization (CRO) status to R&D QA management, follow up on ongoing Corrective Action Plans with Suppliers and participate in strategic initiatives involving CROs
• Maintain effective communication of program related information. Review corrective action plans/audit responses for adequacy and approve if adequate. Review policies and procedures and suggest improvements. Work independently as well as a team. Mentor, coach and train QA auditing staff. Assist with the definition of R&D Quality Goals.
• Prepare and present multiple project progress reports to update management and keep the team(s) informed. Lead/assist/manage external audits by regulatory agencies or customers. Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines. Supervise Quality team members for project specific activities as required.

Basic:

• Bachelors degree in a physical science, life science, nursing, pharmacy or equivalent experience required
• 5-10 years of pharmaceutical industry experience in quality assurance / regulatory affairs
• 5-10 years of clinical research development experience
• 3-5 years of QA auditing experience (GCP auditing highly preferred)
• Minimum of 10 years of total combined experience required (not necessarily the sum of the above)
• Significant Work Activities and Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Key Stakeholders:

This position is accountable to the Associate Director of GCP Compliance, R&D QA. The decisions and recommendations made by the individual will directly impact compliance to applicable regulations, and thereby promote the continued success of R&D.