Director, Quality Assurance
- Employer
- Worldwide Clinical Trials
- Location
- Serbia (RS)
- Salary
- up to 50,000 per annum
- Start date
- 23 Jun 2019
- Closing date
- 23 Jul 2019
View more
- Discipline
- Quality, GCP
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Director/Executive
Job Details
SUMMARY: The QA Clinical Program head is responsible for the oversight, planning, execution, reporting and quality management for assigned Therapeutic Areas within the QA Clinical Oversight Program. This position reports directly to the EVP Global Head of Quality.
RESPONSIBILITIES:
- Serves as the Subject Matter Expert (SME) for Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Management
- Drives process improvements for processes as related to the Quality Oversight Program inclusive of QI/CAPA Management, inclusive of training
- Monitor, tracks, and reports on Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the assigned Therapeutic Area(s)
- Develops QA Clinical Oversight Budget annually
- May serve as the delegate to the EVP Global Head of Quality as necessary
- Serves as an ambassador of the QA organization with internal and external customers
- Participates in the crafting of the QA organizational goals and objectives as assigned
- Plans and manages all resources (budgets, staff, and technologies) for the advancement of the QA’s goals and objectives for the QA Clinical Oversight Program
- Leads a team of Quality Professionals to oversee the delivery of quality deliverables, on time, and in compliance with regulations and Worldwide processes
- Approves work-related travel and expenses reports for direct reports while staying on budget and in compliance with Worldwide Travel Policy
- Ensures compliance with Worldwide’s’ Quality Management System (QMS)
- Champions and adheres to Worldwide’s Quality Management System (QMS)
- Leads regular Issue Management meetings with Functional Area Representatives and delivers reports on trends to the Pulse on Quality Representative.
- Leads/Participates in the development and review of Quality Management Documents
- Develops training materials and/or delivers training as requested
- Participates in risk assessments of Protocols, as necessary
- Serves as the QA Governance representative for Strategy Partners
- Serves as the Subject Matter Expert on QA Quality Management Documents (QMDs)
- Conducts employee performance appraisals as per Worldwide processes
- Provides leadership oversight, supervision, mentorship, and coaching to employees
- 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
SKILLS AND ABILITIES:
- Demonstrated advanced organizational leadership competencies
- Demonstrated ability for driving results and role modeling a cross-functional collaborator
- Demonstrated ability to effectively communicate, escalate, and influence the outcomes of the decision-making process
- Demonstrated advanced project management and decision-making skills
- Demonstrated advanced ability to effectively communicate and influence the outcomes of the decision-making process
- Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
- Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset
- Acts without authority to drive performance and accountability
- Ability to lead a team of individuals with a clear vision and defined purpose
- Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
- Demonstrates an advanced aptitude for facilitating group or project initiatives and building team unity
- Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
- Has a strong understanding of clinical research principles and processes for clinical trials
- Demonstrated advanced ability to implemented risk management strategies
- Demonstrated ability to implemented risk management strategies and participates in protocol risk assessments as necessary
- Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international Regulatory inspections is an asset
REQUIREMENTS:
- Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
- Advanced understanding of the principles for a GCP Quality Management System
- Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree
- Advanced understanding of the Drug Development Process
- Recent experience in leading Process Management activities
- Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature
- Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
- GcLP, GLP, GVP, GPP and GMP knowledge an asset
- Proven experience in developing, managing and complying with annual budgets
- Ability to speak, read and write English fluently
- Bachelor’s degree in nursing, biological, physical, health, pharmacy or other related science; M.S. in scientific or allied health field preferred
- Minimum 12-15 years of relevant GCP, GcLP, GLP, GVP, and GPP experience
- Minimum 5 years managerial experience with direct oversight of a team
- Highly proficient with Microsoft based applications, including Excel, Word, Trackwise, SharePoint, and PowerPoint.
- Domestic and international travel required (approximately 30%)
Company
Find out more about working for our company
Brief Company Description;
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
- Website
- https://www.worldwide.com/
- Mini-site
- Worldwide Clinical Trials
- Telephone
- +44 115 956 7711
- Location
-
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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