GCP Quality Governance Operations Lead - FSP

Primary Responsibilities: u00b7 Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation. u00b7 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. u00b7 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 u00b7 Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion. u00b7 Execution and oversight of the periodic review of GCP quality governance forum remit, charter, scope, membership u00b7 Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training QUALIFICATIONS: General: u00b7 Have a robust understanding of GCP regulatory requirements and the Quality Management System (QMS). u00b7 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. u00b7 Will require pharmaceutical industry acumen. u00b7 Will be an effective communicator, demonstrate domain competency with respect to data privacy, and be familiar with operationalizing global or regional processes. u00b7 Will demonstrates strong analytical and critical thinking abilities, with a track record of identifying and resolving issues effectively Education: u00b7 Bacheloru2019s Degree or equivalent experience a must Years of Experience: u00b7 5+years of related pharmaceutical and/or quality experience Other Specific Skills or Knowledge u00b7 A robust understanding of research and development and GCP u00b7 Project or role-based experience in the following: policy and standards, process management and reporting, and change management/ adoption u00b7 High energy and drive for organization and execution u00b7 Excellent verbal and written communication skills; must be able to interact effectively with professionals at all levels and communicate recommendations with diplomacy and tact u00b7 Strong project management skills, with experience managing time sensitive projects u00b7 Ability to prioritize and demonstrates strong organizational skills and the ability to manage multiple tasks and projects simultaneously u00b7 Advanced skills in all common O365 applications and other reporting tools u00b7 Experience with project management, process tracking or other workflow tools Personal Skills u00b7 Will be compliance driven u2013 ability to balance the needs of the business against quality requirements and controls u00b7 Will have a strong business acumen u2013 ability to understand the needs and concerns of business stakeholders and colleagues, and respond promptly and effectively to stakeholder requests u00b7 Will be collaboration oriented u2013 ability to reach consensus and collaborate across leadership and business groups u00b7 Will be an effective communicator u2013 ability to communicate clearly and effectively with business colleagues as well as legal counsel, other privacy stewards and stakeholder groups ORGANIZATIONAL RELATIONSHIPS u00b7 Partners with quality colleagues across the GCP Quality Management System u00b7 Partners with Business Functions across client R&D #LI-LO1 #LI-REMOTEEEO 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.

Created: 2026-03-17