GCP Quality Governance Operations Lead (Sr Manager) - 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 

Personal Skills 

·       Will be compliance driven – ability to balance the needs of the business against quality requirements and controls 

·       Will have a strong business acumen – ability to understand the needs and concerns of business stakeholders and colleagues, and respond promptly and effectively to stakeholder requests 

·       Will be collaboration oriented – ability to reach consensus and collaborate across leadership and business groups 

·       Will be an effective communicator – ability to communicate clearly and effectively with business colleagues as well as legal counsel, other privacy stewards and stakeholder groups 

ORGANIZATIONAL RELATIONSHIPS 

·       Partners with quality colleagues across the GCP Quality Management System 

·       Partners with Business Functions across client R&D

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.