The QA Lead position is accountable for ensuring implementation and management of the Quality Assurance strategy in a given Therapeutic Area across multiple programs, indications and/or regions. The QA Lead will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to GCP in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
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This position will be responsible to perform risk assessments to identify audit targets, conduct audits, develop and maintain audit tools, as well as, review of audit reports. The QA Lead works to assure quality standards are consistently applied, while allowing for flexible strategies to address the business needs.
The QA Lead will conduct timely and efficient internal communication of resource and data quality matters to Senior Management as appropriate.
This position will require approximately up to 25% time for conducting audits (including travel).
This position will be directly responsible for staff and talent management development, including performance management.
Primary Duties:
Will represent QA as single point of contact for program/s in a certain TA or across TAs in a certain region.
Lead and manage audits across a program/s or region.
Maintain robust audit and quality oversight plans for aligned TA.
May conduct a range of GxP complex audits, (i.e. directed, for-cause) for a given program/s or across TAs in a given region.
Provides Good Clinical Practice, Pharmacovigilance and QA expertise and leadership to the customer.
Contributes to the QA strategy and accountable for the implementation to support goals of the QA function and/or aligned program/product team.
Is accountable for communicating and providing QA strategic guidance across the clinical/project teams, regions and country organizations.
Identifies areas of greatest risk, through intelligence gathering, to proactively and accurately address and complete risk based QA assessments and influence the implementation of robust mitigation strategies (do they need to put in place or influence to put in place mitigation strategies)
In alignment with risk assessments identifies audit substrate for scheduling and resource allocation, as appropriate.
Prioritizes and proactively manages applicable audit schedule, to deliver global audit priorities, modifying as appropriate, to meet the changing business needs.
Monitors and reviews the audit activities, ensures consistency in approach and reporting, and tracking deliverables against the audit schedule.
Maintains knowledge of potential licensing and third party collaboration opportunities, completes risk assessment and conducts assessments as applicable, providing risk and mitigation recommendations.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
Works closely with the applicable QA TA Head and clinical/project/functional teams to understand customer needs in order to develop, refine and adjust strategies and plans, implementing QA activities.
Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements)
Monitors trends, identifies quality issues and determines opportunities for quality improvements within customer areas and QA.
Be able to analyze and leverage quality indicators and data to identify potential trends and risks, and perform root cause analyses to enable principles of knowledge based auditing within respective TA.
Actively participate in Significant Quality Issue management, including assessment of potential root causes and remediation (corrective and preventative actions)
Interfaces with internal QA functions to ensure appropriate quality oversight of the program/product (e.g. TA vendor liaison)
Provides day-to-day support to applicable QA functional line.
Develops and enhances QA procedures, guidance documents and audit tools to ensure QA consistency globally.
Maintains an independent and non-biased role in working with customer area.
Provides guidance and collaborates with QA Specialists, as appropriate, to assure adequate audit focus and timely knowledge transfer.
Provides training and mentorship to less experience members of QA staff.
Possesses high level of expertise within applicable TA and continually enhances knowledge.
Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions and status of competitor/similar products/projects to effectively develop and advance QA strategies.
Is responsible for ensuring delivery of high quality and timely information to appropriate levels of management.
Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues
Provide inspection management support as appropriate
Engages in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.
Requires up to 30% time for conducting audits (including travel) and attending QA meetings.
Ensures the work climate/culture within QA, exemplifies the Merck Leadership behaviors.
Qualifications
Education:
Bachelor’s degree or equivalent experience is required.
Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered.
Required:
Minimum of 10 years QA experience or relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy
Minimum of 5 years of leadership experience, i.e. project teams, line management, etc. with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
Proven ability to function autonomously in a matrix model and in a team environment
Proven business management capability
Proven ability to think creatively and to execute and manage strategic plans
Preferred
Minimum of 3 years of direct people management
Minimum of 3 years of applied clinical/technical Oncology experience in area of responsibility.
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