Regulatory Compliance Quality Operations Manager - Emea - Homebased

Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
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 a Regulatory Compliance Quality Operations Manager does at Worldwide
Reporting to the Director Regulatory Compliance Quality Operations, the Regulatory Compliance Quality Operations Manager is responsible for Regulatory Compliance Quality operational oversight of GxP Quality activities. Ensuring that GxP activities are consistent and meet both external and internal requirements. Provide assurance with SOPs, Regulations, and guidelines for Worldwide processes in collaboration with functional areas. Including managing Quality Issues and CAPA’s, supporting audits and inspections at Worldwide, conducting/oversight of audits of Worldwide vendors and QA oversight of contracts and quality agreements.
What you will do

• Maintains knowledge in relation to GxP activities. Conduct regulatory intelligence/surveillance for GxP requirements globally. Identify quality impact and actions and advise on requirements for Worldwide systems, processes and training.
• Facilitate Identification, and guide continuous improvement in GxP compliance for Worldwide processes, operations and systems.
• Responsible for the GxP compliance of key Worldwide activities including oversight of vendors activities.
• Perform audits and participate in inspections to ensure GxP compliance and ensure observations are reported and CAPA plans implemented to provide assurance of compliance with processes, regulations, guidelines, and agreements. Audits may be part of the internal audit or external vendor programs.
• Provides QA GxP consultancy to the Worldwide operations relating to compliance requirements.

What you will bring to the role

• Demonstrate organizational and critical decision-making skills.
• Engagement and interest in GxP regulations, laws and guidelines with an ability to share and coach.
• Strong understanding of GxP regulations, guidance principles and processes.
• Collaborate effectively with cross-functional stakeholders.
• Fluency in English (speaking, reading, and writing)
• Proficiency in Microsoft applications (Excel, Word, eQMS, PowerPoint)

Your experience

• Bachelor's degree or equivalent in a relevant field (e.g., Science, Computer Science or other related science) and minimum 4 years of experience in a GxP regulated environment (monitoring, data management, PV, clinical trial management, clinical system validation)
• At least 2 years of experience in quality or Regulatory Compliance roles for GxP activities (including for example, QA audits, noncompliance investigations)
• Previous experience participating in regulatory inspections (FDA, MHRA, Health Canada, EMA)
• Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Regulations and Directives, MHRA Statutory Instruments related to relevant GxP.

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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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