GCP Quality Governance Operations Lead (Sr Manager) - FSP

Parexel • Southport, NC

3d

About The Position

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.

Requirements

• 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
• Bachelor’s Degree or equivalent experience a must
• 5+years of related pharmaceutical and/or quality experience
• 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
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level