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For Companies At a Glance
- Tasks: Oversee quality management activities and ensure compliance with regulations.
- Company: Join a global CRO dedicated to innovative healthcare solutions.
- Benefits: Enjoy remote work flexibility and a supportive, inclusive culture.
- Why this job: Make a real impact on patients' lives while growing in a dynamic team.
- Qualifications: 4+ years of GCP experience and a degree in a related field required.
- Other info: Opportunity for mentorship and collaboration with industry experts.
The predicted salary is between 36000 - 60000 £ per year.
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 3,500+ 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.
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
What the Quality Assurance Department does at Worldwide
The Senior Quality Management Associate (Senior QMA) is responsible for the oversight, delivery, maintenance, reporting, and follow up of assigned QA activities.
What you will do
- Champions the adoption of the Quality Management System (QMS)
- Provides consultancy and oversight for project-specific Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans
- Maintains up to date electronic filing and management for QI and CAPA related documentation
- Acts as GCP/GLP/GcLP Subject Matter Expert (SME), provides GCP/GLP/GcLP consultancy to project teams and for assigned functional area(s)
- Performs study data review and trending activities as assigned
- Collaborates with Risk Based Quality Management to support ongoing risk assessment as assigned
- Responsible for QA review of assigned QMDs during revisions or regular review cycles
- Works collaboratively with the Quality Lead (Therapeutic Area Quality Lead, Bioanalytical Quality Lead, or Phase 1 Clinic Quality Lead)
- May assist with Sponsor audits and regulatory inspections as assigned
- Acts as mentor to Quality Management Associates
- Performs other duties as assigned.
What you will bring to the role
- Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
- Customer focused approach to work
- Demonstrates critical thinking skills
- Serves as a positive QA ambassador during all daily activities and customer interactions
- Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines
- Demonstrates an ability to effectively communicate and influence the outcomes of the decision-making process
- Works with a sense of urgency and recognizes and delivers on time sensitive deliverables
- Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks
- Adheres to Worldwide Travel Policy
Your experience
- Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
- Ability to speak, read and write English fluently
- Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP
- Working knowledge of the Drug Development Process
- IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint
- College / University degree or equivalent in biological sciences, nursing, pharmacy, or other related science and 4+ years of relevant GCP experience
- GcLP, GLP, GVP and GPP experience is an asset
- Domestic and international travel may be required (not exceeding 10%)
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.
Senior Quality Management Associate - Fixed-term - UK/EU - Remote employer: WCT Worldwide Clinical Trials GER GmbH
Contact Detail:
WCT Worldwide Clinical Trials GER GmbH Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Management Associate - Fixed-term - UK/EU - Remote
✨Tip Number 1
Familiarise yourself with the latest trends and regulations in Quality Management Systems (QMS) and GCP. This will not only help you understand the role better but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the CRO industry, especially those who work in quality assurance roles. Engaging in conversations can provide insights into the company culture at Worldwide Clinical Trials and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled quality issues or CAPA plans in your previous roles. Being able to articulate your experience clearly will showcase your expertise and problem-solving skills during interviews.
✨Tip Number 4
Research Worldwide Clinical Trials' mission and values thoroughly. Understanding their commitment to diversity and inclusion can help you align your responses during interviews, showing that you share their vision and are a good cultural fit.
We think you need these skills to ace Senior Quality Management Associate - Fixed-term - UK/EU - Remote
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management and GCP. Use keywords from the job description to demonstrate that you meet the specific requirements of the Senior Quality Management Associate role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the role. Mention specific experiences where you've successfully managed quality issues or implemented corrective actions, aligning them with the responsibilities outlined in the job description.
Showcase Your Communication Skills: Since the role requires professional communication, include examples in your application that demonstrate your ability to communicate clearly and effectively, both verbally and in writing. This could be through previous roles or projects where you had to liaise with various stakeholders.
Highlight Relevant Qualifications: Ensure you mention your educational background and any certifications related to quality management and regulatory compliance. If you have experience with Quality Management Systems or GxP activities, make it prominent in your application.
How to prepare for a job interview at WCT Worldwide Clinical Trials GER GmbH
✨Understand the Quality Management System
Familiarise yourself with the principles and applications of Quality Management Systems (QMS) relevant to GCP. Be prepared to discuss how you have implemented or improved QMS in your previous roles.
✨Showcase Your Critical Thinking Skills
Demonstrate your ability to think critically by providing examples of how you've tackled complex quality issues in the past. Highlight your problem-solving approach and the outcomes of your decisions.
✨Communicate Clearly and Professionally
Practice articulating your thoughts clearly and concisely. Since the role involves communication with both internal and external stakeholders, be ready to showcase your verbal and written communication skills during the interview.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your ability to manage quality issues and corrective actions. Prepare specific examples from your experience where you successfully navigated similar challenges.
