GCP Quality Governance Operations Lead (Sr. Manager)

Parexel • Honolulu, HI • 1d ago

Parexel FSP is looking for a GCP Quality Governance Operations Lead in Argentina.

The GCP Quality Governance Operations Lead is responsible for providing strategic and operational expertise to drive the management (planning, execution and follow-up of GCP Quality governance forums, councils and committees.

Serves as a liaison and SME for teams on the quality governance process and leads teams in planning and preparation for governance interactions.

Manages the development and oversight of Metrics generation to support compliance and impact/trend analysis across governance reviews.

Uses process experience and expertise to implement process workflow improvements and efficiencies and improvements in the process and documentation.

Oversees quality governance tools, tracking and mechanisms

Facilitates and oversees the annual governance charter review process

Role Responsibilities:

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.

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