Manager, Quality Management Oversight

Requisition Number: 6067

Position Title: Manager, Quality Management System

External Description:

SUMMARY: The manager, Quality Management System (QMS) is responsible for the ongoing evaluation of the Quality Management System adoption, effectiveness, and strategic alignment with Corporate Goals, Quality Objectives and for identifying areas for process improvements in a GCP / GLP Environment. 
 
RESPONSIBILITIES:

• Champions and adheres to Worldwide’s Quality Management System (QMS)
  • Facilitates proactive, cross-program dialogue and decision-making regarding the QMS adoption by fostering a culture that values and rewards critical thinking and open dialogue about quality.
• Responsible for assessing the effectiveness of the Quality Management System by:
  • Reviewing the internal and external environment for which the QMS operates to ensure efficiencies and effectiveness;
  • Reviewing customer and stakeholder requirements related to quality aligns with the design of the QMS;
  • Reviewing methodologies used to monitor and report Key Quality Indicators (KQIs) and Quality Tolerance Limits (QTLs) to the Quality Management Council;
  • Reviewing critical-to-quality factors identified by Quality System Element Governance Committees and aiding in their implementation;
  • Ensuring alignment of quality objectives with regulatory requirements and strategic objectives;
  • Assessing Areas for process improvements within the QMS;
  • Reviewing and seeking customer feedback from stakeholders directly impacted by the QMS.
• Serves as a liaison between QA Programs to ensure alignment in activities, consistency, and completeness in processes and drives effective communication.
• Serves as a backup for the system owner of the QMS electronic systems (e.g. SharePoint Site, PowerBI, TrackWise, Pilgrim).
• Supports ICP Business & Analytics in the review and tracking of Sponsor Master Service Agreements and Change Orders for QA activities and responding to Proposals and Business Development for QA requests and questions, including reconciliation of approved budgets against actuals and tracking of new and executed QA contracted activities against QA budget.
• Supports Document Control as requested for Project Initiatives, Quality Control activities, and records management as assigned.
• Supports Audits & Inspections with record management as assigned.
• Supports Quality Clinical Oversight Program with Quality Agreements, Quality Issues / Corrective and Preventive Actions, and record management, as assigned.
• Executes individual goals for the QA organization.
• May participate in departmental or cross-functional initiatives as assigned.
• Performs other duties as assigned in support of QA activities.

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive


OTHER SKILLS AND ABILITIES:

• Communicates professionally, positively, concisely, clearly, and consistently to external and internal customers both verbally and in writing.
• Client-focused approach to work.
• Demonstrates strong critical thinking skills.
• Demonstrates the ability to successfully plan, adjust, manage and optimize all resources for the advancement of QA goals and objectives.
• Maintains a positive, results-oriented work environment, building partnerships within the group and across the organization at large, modeling teamwork.
• Serves as a positive QA ambassador during all daily activities and customer interactions.
• Demonstrates strong aptitude for facilitating group or project team activities and building team unity.
• Demonstrates a strong ability to effectively communicate and influence the outcomes of the decision-making process.
• Proven ability to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines.
• Demonstrates strong skill set for influencing, being resourceful, managing conflict, and negotiating.
• Works with a sense of urgency and recognizes and delivers on time-sensitive deliverables
• Works independently, take initiative, and has a flexible approach to work assignments and other assigned tasks.
• Demonstrated strong ability to implement risk management strategies.
• Ensures resources are adequate, if not, provides a business case to senior management.
• Provides coaching, mentoring, and constructive feedback to employees inclusive of peer performance evaluations and individual training programs, as assigned.
    

REQUIREMENTS:

• M.S. in a scientific or allied health field and 3+ years of relevant GCP, GLP, and GVP experience
  Or a Four-year college curriculum with a concentration in biological, physical, health, pharmacy or other related science and 5+ years of relevant GCP, GLP, and GVP experience
• Ability to speak, read and write English fluently.
• Strong working knowledge of ICH Guidelines, FDA regulations, European Directives, and MHRA Statutory Instruments.
• Strong understanding of the Drug Development Process.
• Strong working knowledge of IT systems, experienced with Microsoft-based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint. Experience with data visualization tools such as Power BI, Spotfire or Tableau is desirable, but not required. 
• Domestic and international travel required (approximately 10%)

 

City:

State:

Employment Type: Regular

Community / Marketing Title: Manager, Quality Management Oversight

Company Profile:

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: Tennessee, US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.