Manager Audit Services

Are you seeking a purposeful and rewarding Audit Services career opportunity, where you can deliver high-quality professional services for our customers and patients?
Our Quality Assurance & Regulatory Affairs division is growing, and with big ambitions and a clear vision for the future, now is the time to join Clario as a Manager of our Audit Services team, working remotely from the UK.
What we offer:

• 
  Competitive compensation
• Attractive benefits (security, flexibility, support, and well-being)
• Engaging employee programs
• Remote working & home office set up

What you will be doing:
The Manager, Audit Services is responsible for the overall execution of Clario's audit programs, which includes: -

• 
  Managing a team of 4 Quality Assurance Auditors
• Responsible for administering and coordinating all External Audits globally
• Internal audit projects
• Identifying and/or developing tools to facilitate the execution of cross business unit audits
• Responsible for the identification and routine reporting of performance metrics
• Ensuring compliance and execution of the Internal/Vendor program in accordance with ICH E6 GCP, 21 CFR Part 820 and ISO standards – including but not limited to 9001 and 13485
• Lead the investigation of any suspected instances of Clinical Misconduct/Fraud

What we look for:

• 
  Minimum 5-7 years relevant experience preferably in a GxP regulated environment
• Working knowledge of pharmaceutical GxP, ICH and ISO 9001/13485 requirements
• Relationship builder who is solutions-oriented and can effectively link the interests of multiple stakeholders
• Most have a strong technical writing skill set and be able to critically review reports and effectively develop/guide development of appropriate observation responses
• Team leader who can establish priorities and ensure optimal allocation of resources
• Change management and process reengineering capabilities- ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones
• Excellent organizational, interpersonal, verbal, and written communication skills

It would be an advantage if:

• You are already well-versed in various software
• You have already had touchpoints in the field of clinical studies or knowledge of the drug development process

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It is only through our people that we can continue to innovate technology that will shape the future of clinical trials. Courageously Curious

Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We’re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.

Behaviors:

• We learn; embracing change, questioning how we work, finding a better way. And if it doesn't go to plan, we don't blame each other; instead, we own it and grow together
• We partner' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Deliver Exceptional

We step forward because responsibility powers us; we don’t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.

Behaviors:

• We prioritize; focusing on what matters, never compromising on quality.
• We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients—and each other. We’re united by our purpose—it’s why we go above and beyond to support each other, emphatically.

Behaviors:

• We do the right thing; for our customers, patients, sites and each other. And We're passionate about it.
• We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed.