Senior Manager, Quality Systems - Europe - Remote

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. 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.

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%).

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.