Executive Vice President, Head of Global Quality
Location: Morrisville, North Carolina, United States
Requisition Number: 1241
Position Title: Executive Vice President, Head of Global Quality
ROLE: EXECUTIVE VICE PRESIDENT, HEAD OF GLOBAL QUALITY
The Global Head of Quality is responsible leading the independent Quality Assurance (QA) organization at WORLDWIDE to ensure QA projects, products and programs are in compliance with all applicable global regulations and guidance’s, Worldwide Clinical Trials Policies and Standard Operating Procedures (SOPs) and applicable Client SOPs.
- Tasks may include but are not limited to:
- Serves as the Head of Global Quality reporting to Worldwide Chief Operating Officer (COO) and dotted line to the Chief Executive Officer (CEO)
- Serves as a core member of the Worldwide Senior Leadership Team
- Champions a culture of quality across Worldwide by the following;
- Oversees the execution of the QA strategy as defined in the Quality Manual for all Worldwide regulated activities
- Directs and actively responsible for the development, oversight of implementation, and maintenance of the Risk Based Quality Management System (QMS), inclusive of development and reporting of a Risk Compliance Report to Senior Management
- Oversees the development, governance, adherence and reporting of appropriate processes for global procedural practices in alignment with the QMS
- Promotes quality improvements based on compliance trends to established quality standards and measurements
- Sponsors quality initiatives as identified by the Senior Leadership Team
- Oversees the development of content for GxP training as necessary both internally and externally
- Serves as a subject matter expert for GxP quality principles
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as they relate to GxP and Quality Management Systems.
Leads the QA organization by the following:
- Oversees the QA organization to ensure adequate resources (talent, structure, budget, time) are in place to adequately implement the Quality Strategy and meet Corporate objectives
- Leads the development of QA organizational goals in alignment with company goals and objectives and ensures line of sight to QA individual goals
- Oversees the escalation, reporting, investigation and management of critical quality issues to resolution
- Oversees QA activities as related to study oversight, vendor management, compliance and inspection management, process improvements, training, regulatory intelligence, quality issue and Corrective and Preventive Actions (CAPA) management
- Serves as a coach/mentor for staff to improve performance and foster professional development
- Promotes and fosters professional development of the QA team through continuing education opportunities
- Approves work related travel and expenses for direct reports
- Ensures QA organization establishes and maintains effective cross functional team/client communications to advance quality at Worldwide by being trusted partners
- Leads by example Worldwide’s Core Values for delivering with excellence, taking ownership, acting with integrity, embracing teamwork and be tenacious.
Corporate Compliance Responsibilities include:
- Oversees management of Global Data Protection & Privacy requirements to ensure and demonstrate that data processing at Worldwide Clinical Trials is performed in accordance with global data protection laws and regulations, including, but not limited to, the provisions of the European Union (EU) Global Data Protection Regulation (GDPR).
- Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
- Prior Management experience in leading a functional or global QA team.
- S. in a scientific or allied health field and 12+ years of relevant GxP experience,
- Experience serving in a Quality Management role
- Demonstrated leadership skills
- Proficient in using Microsoft Office Applications
- Domestic and international travel required (approximately ~10-20%)
- Demonstrates expert abilities to successfully plan, adjust, manage and optimize all resources for the advancement of Worldwide QA goals and objectives.
- Demonstrates broad expertise related to understanding the principles and applications of quality and regulatory compliance as related to GxP
- Demonstrates highly skilled aptitude for facilitating group or project team endeavors and building team unity
- Excellent oral and written communication skills
- Ability to influence with authority
- Proven record for being a results driven leader
- Recognized ability for being a cross functional collaborator
- Continuous Learner
- Verifiable experience in building high performing teams and for attracting top talent
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Executive Vice President, Head of Global Quality
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Morrisville, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.