GCP Quality Governance Operations Lead - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Primary Responsibilities: 

·       Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation. 

·       Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics. 

·       Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency.  Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement 

·       Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion. 

·       Execution and oversight of the periodic review of GCP quality governance forum remit, charter, scope, membership 

·       Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training 

QUALIFICATIONS:  

General: 

·       Have a robust understanding of GCP regulatory requirements and the Quality Management System (QMS). 

·       Will be able to engage directly with various business representatives, business process owners, and leadership teams to assist with the adoption of consistent data privacy practices. 

·       Will require pharmaceutical industry acumen. 

·       Will be an effective communicator, demonstrate domain competency with respect to data privacy, and be familiar with operationalizing global or regional processes. 

·       Will demonstrates strong analytical and critical thinking abilities, with a track record of identifying and resolving issues effectively 

Education: 

·       Bachelor’s Degree or equivalent experience a must 

Years of Experience: 

·       5+years of related pharmaceutical and/or quality experience 

Other Specific Skills or Knowledge 

·       A robust understanding of research and development and GCP 

·       Project or role-based experience in the following: policy and standards, process management and reporting, and change management/ adoption 

·       High energy and drive for organization and execution 

·       Excellent verbal and written communication skills; must be able to interact effectively with professionals at all levels and communicate recommendations with diplomacy and tact 

·       Strong project management skills, with experience managing time sensitive projects 

·       Ability to prioritize and demonstrates strong organizational skills and the ability to manage multiple tasks and projects simultaneously 

·       Advanced skills in all common O365 applications and other reporting tools 

·       Experience with project management, process tracking or other workflow tools