Senior Manager, Quality Systems - Europe - Remote

Worldwide Clinical Trials; United Kingdom; Remote; GBP 50,000 - 75,000; Full time

Job summary

A leading clinical research organization is seeking a Quality Assurance Project Manager to oversee Quality Management Systems projects. The ideal candidate will have extensive GxP experience, strong project management skills, and a commitment to quality and continuous improvement. Join a team dedicated to making a difference in patients' lives.

Qualifications

• Minimum of 7 years of relevant GxP experience.
• Advanced understanding of clinical research principles.
• Expert knowledge in GxP Regulations and guidance.

Responsibilities

• Manage and coordinate Quality Management Systems projects.
• Execute regulatory intelligence strategy and monitor GxP changes.
• Facilitate continuous improvement initiatives based on regulations.

Skills

Communication

Critical Thinking

Influencing

Project Management

Decision Making

Education

Bachelor’s degree

MS in a scientific or allied health field

Job description

Who we are

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.

Why Worldwide

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.Join us!

What the Quality Assurance Department does at Worldwide

The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.

What you will do

• Responsible for the project management and coordination of Quality Management Systems projects initiative. Driving continuous improvement and efficiencies across the QA function.
  
• Execute the regulatory intelligence strategy that is defined by the QMS Department Leader while developing the tools to enable proactive monitoring, gathering, and analyzing regulatory data from sources to identify relevant GxP changes.
  
• Builds and fosters strong cross functional relationships with internal and external stakeholders to facilitate information exchange by serving as QMS Project Manager.
  
• Ensures impact assessments to determine how regulatory changes affect Worldwide’s operations, ensuring that most critical updates are prioritized and completed.
  
• Communicates via reports, regulatory intelligence outputs, regulatory intelligence meetings, Lunch and Learns and other training methods to inform stakeholders about learnings, trainings, changes in regulations and processes.
  
• Facilitation of continuous improvement initiatives triggered by regulations. Manage the project management of RIC recommendations in collaboration with the RIC co-chair and Senior Director, QMS to meet regulatory standards and drive continuous improvements.
  

What you will bring to the role

• Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process.
  
• Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset.
  
• Demonstrated skills for influencing, being resourceful.
  
• Works with a sense of urgency; ability to recognize time sensitivity and leads assertively.
  
• Has an advanced understanding of clinical research principles and processes for clinical trials.
  
• Experience with identifying and project managing regulatory changes within life sciences organizations.
  
• Expert knowledge in GxP Regulations and guidance.
  

Your background

• Bachelor’s degree; MS in a scientific or allied health field preferred.
  
• Minimum of 7 years of relevant GxP experience.
  
• Advanced knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments. Broad expertise related to understanding the GxP global requirements - regulations, laws and guidelines.
  
• QA Project Management experience.
  
• Advanced understanding of the Drug Development Process.
  
• Domestic and international travel required (approximately 10%).
  

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .

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 know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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.