GCP Quality Governance Operations Lead (Sr Manager) - FSP

Parexel • Nashville, TN • 7h ago

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

LI-REMOTE

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.

Parexel

Go to Apply

Share this job

Similar Jobs

Tech Partner Marketing Strategy Manager

Accenture • Nashville, TN • 5h ago

Management & Administrative

We are: Accenture Song accelerates growth and value for our clients through sustained customer relevance. Our capabilities span ideation to execution: growth, product and experience design; technology and experience plat...

5h ago

Go to Apply

Supply Chain and Operations Consulting - Sourcing and Procurement Senior Manager

Accenture • Nashville, TN • 6h ago

Management & Administrative

We are:Supply Chain, and we move fast, think fast, and work fast. Our Fortune 500 clients need big-picture change, so we come at their challenges from all sides with functional insights, data power, digital leadership, a...

6h ago

Go to Apply

Senior Software Configuration Management Engineer/ Senior System Center Configuration Manager (SCCM)

Amentum • Nashville, TN • 14h ago

Management & Administrative

Amentum is a global leader in advanced engineering and technology solutions, trusted by the United States and its allies to address their most significant and complex challenges in science, security, and sustainability....

14h ago

Go to Apply

Licensed Land Surveyor / Surveying Manager

Johnson, Mirmiran, and Thompson Inc. • Franklin, TN • 16h ago

Management & Administrative

Johnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm with more than 2,800 professionals, providing a full range of multidisciplinary engineering, architecture, information technology, and re...

16h ago

Go to Apply

PwC Technology - Quality Management Lead

PwC • Nashville, TN • 19h ago

Management & Administrative

Specialty/Competency: IFS - Internal Firm Services - Other Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 20% At PwC, our people in information technology operations focus on managing and...

19h ago

Go to Apply

Administrative Assistant I

RES • Nashville, TN • 1d ago

Management & Administrative

Description We are committed to building a workplace where everyone feels heard and respected, and extending our culture of care so that every individual can reach their full potential. We want you to have a sense of bel...

1d ago

Go to Apply

Regional Account Manager - Lubricants

Clean Harbors • Nashville, TN • 1d ago

Management & Administrative

The Lubricant Sales Specialist, known internally as a Blended Oil Specialist, focuses on building business within their territories as well as developing and maintaining strong customer relationships. Why work for Safety...

1d ago

Go to Apply

Reverse Logistics Coordinator, OTS Supply Chain - Global Transportation & Logistics

Amazon • Antioch, TN • 1d ago

Management & Administrative

Description Amazon is looking for a Reverse Logistics Coordintor to support the non-inventory movement of new/used technology returns to Global RAD Operation sites (GRO) around the world. This is an exciting opportunity...

1d ago

Go to Apply

Senior Manager, Launch Manager, NA Launch & Expansions (AMZL + RSR)

Amazon • Nashville, TN • 1d ago

Management & Administrative

Description We are seeking an experienced Senior Manager, Program Managment, to join Last Mile Launch Execution, with a breadth of Amazon experience across different business units and pillars for an exciting role in the...

1d ago

Go to Apply

Relief Account Sales Manager

Keurig Dr Pepper • Nashville, TN • 2d ago

Management & Administrative

Job Overview: Relief Account Sales Manager for Greater Nashville, TN Hiring Immediately The Relief Sales Manager is responsible for up-selling and fulfillment/replenishment, focusing on execution and merchandising. This...

2d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.