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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
GCP Quality Governance Operations Lead - FSP
Job ID R0000039740Primary 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
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