Senior Specialist, Global Quality Systems - Hybrid

Job Description

The mission of our company’s Research Laboratory Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).

The Senior Specialist role reports into the Global Quality Systems organization, within CQMS, and is responsible for the execution of quality systems activities in support of the clinical supply chain for investigational medicinal product within our company's Global network.  This role supports the digital enablement of quality systems, such as document control, deviation management, change control and quality risk management and will be instrumental in the development and implementation of new IT solutions quality system modules for these areas.

The responsibilities of this role include, but are not limited to:

• Provide key quality systems support and ensure that systems and processes are operating in a state of control and in compliance with regulatory requirements and internal SOPs.

• Support the document control function, including the oversight of the Electronic Document Management Systems (EDMS) and training systems, issuance and archival of GMP documentation and revision of SOPs, primarily through the management of document lifecycle (new or existing documents) and review/approval workflows.

• Support and drive the ongoing implementation and long-term maintenance of a new QMS, including Development Quality Standards and Development Global Standard Operating Procedures for all Clinical Supply sites within our company's Global network.

• Leverage project management skills to support the digital enablement of quality systems, such as document control, deviation management, change control and quality risk management.

• Support the planning, coordination, implementation, and organizational change management of IT initiatives from a business perspective, such as system enhancements and automation to improve clinical supply GMP processes.

• Work to significantly harmonize diverse Clinical Supply site practices by developing efficient, yet flexible Global SOPs and effectively implement at all sites with Clinical Supply functions.

• Support key quality system and compliance projects within the global network aimed at elevating our compliance posture and enhancing our quality systems.

• Proactively identify, develop and implement opportunities for improvement and efficiency; with the goal of continuously improving processes.

• Work across multiple organizations to solicit internal and external feedback and to influence and implement solutions.

• Promote a culture of quality and operational excellence.

• Author, review and/or approve GMP documents, as per procedures or need

• Support training curriculum development, review and optimization

• Support the development of quality metrics and KPIs to monitor the performance of the quality systems.

Education Minimum Requirement: 

• B.S degree in an appropriate Science or Engineering discipline or 5 years’ experience (equivalent).

Required Experience and Skills:

• Experience in pharmaceutical/biotechnology industry with three (3) years in a technical, quality or compliance role. 

• Knowledge of GxPs and technical aspects of support areas are required.

• Excellent communication and presentation skills with the ability to effectively collaborate with cross-functional and cross-divisional teams and stakeholders at all levels.

• Ability to prioritize and manage multiple projects simultaneously, ensuring timely delivery and meeting business objectives.

• Highly organized with effective project management skills.

Preferred Experience and Skills: 

• Previous background directly related to quality assurance, quality systems, auditing, quality management systems or other GMP compliance activities.

• Strong computer skills, experience with Veeva Vault Quality Platform

• Effective negotiation and problem-solving skills.

• Ability to lead teams in a matrix organization to achieve objectives, including collaboration, influence w