Senior Manager, R&D Quality Assurance

The Sr. Manager, Research and Development (R&D) Quality Assurance will independently perform the duties of the QA Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies, ensuring the conduct and compliance of clinical trials in alignment with the Protocol, International and Local Regulations. The Snr. Manager will Lead inspection readiness for assigned studies and lead/support audit activities as required.

Summary of Key Responsibilities:
·Independently execute the R&D Program Lead (PL) role, with escalation support from the GCP QA director, as guided by Program Lead Plan. The PL role will be working with Expertise Areas to oversee key areas of compliance with the protocol, company SOPs (Standard Operating Procedures), Good Clinical Practice (GCP), and Regulatory Guidance, including:
o As directed by the PL Plan and with consideration to the risk and complexity of the clinical trial;
§ Lead the development and execution of study audit plans, support Investigator Sita Audit (ISA) selection, develop audit agendas, audit reports, and CAPAs (Corrective Action and Preventive Action) for managed audits or oversee CRO managed ISA activities. Co-audit/lead ISAs, as required.
§ For Phase 2 & 3 trials, lead the development and execution of quality activities through endpoint de-risking to identify, manage, and report key study risks.
§ Develop and execute PL Oversight of assigned clinical studies as guided by the PL Plan. This includes, but is not limited, to risk-based reviews of key study documents against the PL Plan, and assessment of EA clinical trial activity and outputs in compliance Protocol, ICH-GCP, Health Authority guidance and regulations, procedural documents and best practices.
§ Execute the Quality Event QA roles for study specific compliance issues, including sponsor non-compliance, clinical site non-compliance, and vendor non-compliance through guidance on appropriate investigations, root cause analyses, impact assessments, and corrective and preventive action plans.
o Provide guidance to other Program Leads and oversee assigned other R&D QA junior staff assigned to the study where the PL executes the PL role.
o Establish and maintain good working relationships with internal Expertise Area (EA) Leads and external partners.
·Provide ad-hoc GCP quality guidance to groups within the organization.
·Own and drive inspection readiness efforts for assigned clinical studies, with oversight from the Director, GCP QA (or designee);
§ Oversee the completion of the IR workstream completion for all workstreams, including workstreams owned by EAs.
§ Create workstreams for all Inspection Readiness topic areas, create inspection readiness workstreams with details for EAs on how to execute the workstreams, as required to be inspection ready for EMA (CHMP), FDA (BIMO), PMDA and other Health Authority inspections.
§ Participate in preparation for regulatory inspections, overseeing assignment of all IR workstreams and owning assigned IR workstreams, providing guidance to EAs and other QA team members to deliver IR activities, core presentations and back-up presentations.
§ Execute assigned roles in the front room and backroom and provide insight to the Process Quality Excellence team on who is best able to execute other front-room and back-room roles.
§ Identify sites of interest and lead Site Inspection Readiness Training visits
§ Management of inspection related CAPAs & Quality Events.
§ Manage site level inspections, with support from the Director, GCP QA (or designee)
· As directed by the GCP QA Director, support QA Vendor Quality Oversight (VQO) audit team:
§ Provide input towards Vendor Audit scope for vendors that support assigned Clinical Trials
§ Support the review of vendor audit and CAPA responses.
§ Co-audit vendor audits as required.
· As directed by the GCP QA Director, support QA Process Quality Excellence (PQE team):
§ Support multi-study/process related QEs, as required.
§ Lead and Co-Audit assigned Process Audits
§ Participate in assigned Process Improvement initiatives, providing SME input.
§ Participate in Program Lead Plan updates, PL tools, and QA SOP/WI updates.
§ Support assigned Regulatory Intelligence reviews.
·Grow and maintain relevant knowledge of both local and international auditing and appropriate GxP requirements and developments as they impact SOPs and compliance with GxP.
·Travel on assignment, average of 10-25%.
·Other assignments as directed by the Quality Assurance management team.

Qualifications:
·Educated to bachelor’s degree level, preferably life science (technology, biological science, pharmacy, or other health related discipline preferred) or equivalent qualification or clinical research experience. Master’s degree in a science, technology, or industry related discipline, preferred.
·Seven years’ experience in GCP Quality Assurance, or similar experience working in GCP and clinical trial that support pharmaceutical development.
·Experience in Overseeing late phase clinical trials.
·Experience in leading audits.
·Experience supporting and leading inspections readiness efforts and direct inspection experience.
·Extensive experience working with different Quality Assurance functions, knowledge of Auditing, Clinical Supply Chain, Clinical Operations, Monitoring, Regulatory Affairs, Clinical Research, Drug Safety and Data Management and Statistics
·Strong working knowledge & knowledge of how to interpret GCP regulations as well as industry guidance (e.g., FDA, EMA, and other national agencies).

Pay ranges between $85-93/hr based on experience