Job Summary

The Director, PV QA Americas, reports directly to the Senior Director, PV QA Americas, Global R&D & PV QA. This position is accountable for instilling a consistent quality mindset and culture through partnering with stakeholders to streamline the development and the conduct of company's risk mitigation strategies. The Director will provide operational QA involvement, ensure requirements are in place for quality oversight of marketed products under REMS program, and oversee such programs from a QA perspective. The incumbent will collaborate with internal QA stakeholders, including GMP QA, and support continuous improvement initiatives. The Director may represent QA at governance meetings and cross-functional projects as needed. The position will represent QA at Global CSPV LT, Development (as applicable), GMP QA, and engagement with external partners as deemed necessary. This position is accountable to drive a proactive approach to quality and instilling a shared passion for building a stronger Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders. The incumbent must aim to instill a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Ensure requirements are in place for quality oversight of marketed products under REMS program in collaboration with internal QA stakeholders such as GMP QA, specifically for GDP requirements, risk-based assessment for Distributors, vendors, and pharmacies. Liaise with Audit and Compliance team to ensure that REMS audits are planned, communicated and that audit targets for tactical and strategic REMS audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within CSPV and other impacted stakeholders. Improve QA engagement with the relevant stakeholders at the regional DSI level as well as influence at the global level pertinent to metrics, lessons learned and improved processes. Provide end to end safety consultation impacting REMS products from a quality perspective. Provide updates to management on MTS strategy for PV QA area and propose improved objectives as necessary. Deliver methods for risk areas/process improvement to stakeholders via the QMS scheme (i.e., Quality Management Review, Quality Review Board) across the impacted organization leaders and relevant external stakeholders. The role will participate in other PVQA Americas projects, tasks, and initiatives as needed and as instructed, including but not limited to including Quality Oversight for the Quality Plan execution, review of key REMS documents, Health Authority Commitments, Incidents, escalation process and the CAPA Management Process for the respective functional areas.

Job Description

Responsibilities

Provide REMS quality oversight of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy.
Lead the REMS inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, specifically in the DSI.
Act as the PV QA REMS representative for key health authority inspections such as US FDA, Health Canada, ANVISA, etc.
In collaboration with stakeholders develop Lessons learned information flow at the operational level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement. Ensure adequate CAPAs are defined, implemented, and closed by providing guidance and facilitation of quality event resolution.
Proactively ensure that all functions consistently operate in a state of compliance
May be tasked as a QA reviewer to support/ lead the review of the safety section of the dossier for regulatory submissions in collaboration with the Audit and Compliance team
Ensure that REMS topics, risks, respective product profile targeting the population are addressed from a PV QA standpoint and represent QA at respective governance meetings where QA is necessary. Support Head of PV QA Americas to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Ensure that safety risks are duly identified, mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas. Provide strategic direction pertinent to REMS activities for internal QA team (global/ local), and not limited to:
Global Project Teams
Safety Management teams
Clinical Safety and Pharmacovigilance
Companion Diagnostics/ Device
Pharmacies
Vendors/ CRO
Commercial May deputize for the Head PV QA Americas at Leadership teams, as appropriate and as needed.
Contribute to the strategic road map, metrics, dashboard, and project management methodologies for an efficient and effective organization.
Support the annual global quality objectives, strategic initiatives to deliver against the business plan.

Responsibilities Continued

Qualifications

Education Qualifications
Bachelor's Degree Bachelor's degree in scientific, health care or related discipline; and/or background in Medical Health profession (RN, Medical Technologist, etc.). Master's preferred required Master's Degree preferred

Experience Qualifications
10 or More Years 10 or More Years of involvement in regulated activities, clinical development, CSPV and QA (preferably) positions, or equivalent experience required required
10 or More Years 10 or More Years broad understanding of global expectations of Health Authorities in the in the management of clinical trials and REMS programs; preferred preferred
10 or More Years 10 or More Years understanding of the science of product development; preferred preferred
10 or More Years 10 or More Years Thorough and extensive knowledge of international GCP, GvP regulations including FDA/EU GCP, ICH. preferred preferred
Excellent verbal and written communication skills/ computer skills
Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation.
Cable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas.
Issues are adequately and timely escalated.
An effective process for CAPA monitoring is implemented in collaboration with the QA audit team.
Audits and HA inspections are effectively prepared and managed resulting in successful audits and HA inspections.
Experience in QA oversight of REMS programs

Additional Information