Blue Bell, PA (US) Hybrid

Are you ready for the Most Impactful Work of Your Life?

Signant Health is a global evidence-generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations and reimagining the path to proof.

Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry.

Where do you fit in?
We are looking for a Senior Manager, Audit to lead the team that focuses on providing leading support to the entire organization as it relates to audit management, which is an integral part of our business. We are looking for a candidate that is a self-starter, results oriented individual with ability to articulate, receive, disseminate, and analyze information to join our company to be responsible for client audit hosting, which includes managing a team of Audit Specialists, working with our clients to schedule audits, oversees CAPA assignment, provide leadership for audits, and hosts audits amongst improving overall audit processes etc.

As part of our team, your main responsibilities will be:

• Oversee the client audit program from beginning to end
• Work with customers on a regular basis to solve issues and satisfy customer needs, translate needs into internal directions/activities which lead to solutions.
• Schedule, manage, coordinate, host (as necessary), and participate in customer audits, and ensure 100% on-time responses to findings and completion of commitments.
• Partner with key cross-functional teams to strengthen the identification, quantification and effective treatment of audit management.
• Develop and drive continuous improvement opportunities in relation to the audit process as well as identify trends in audit findings.
• Liaise with internal and external partners to develop strong diligence according to internal policies regarding audit management.
• Understand our product offerings and actively assess ways to apply knowledge to further support client audits.
• Develop long term relationships and networks both internally and externally.
• Assess, document and communicate risk exposure across the enterprise.
• Make recommendations on internal tools and processes to gain efficiencies in audit management activities.
• Maintain and organize the client audit calendar.
• Be a point of contact for customer’s regulatory inspections.
• Co-manage Signant Health’s regulatory inspections.
• Train and mentor other team members.
• Lead and manage the successful review of projects and client audits.
• Maintain documents and records in accordance best practices and applicable regulations etc.
• Act as SME responding to client audit questions and issues from both internal and external sources.

You’ll need to bring:

• Experience working with customers
• Experience as an auditor and/or an audit host
• Proven understanding of GxP regulations pertaining to clinical trials and software solutions.
• Distinguished project management, business system analysis, strategic planning, process documentation skills
• Improve strategic data insights to influence partners on project decisions.
• Ability to build positive relationships with our clients and internal business teams is crucial.
• Ability to lead and participate in cross functional global teams.
• Ability to work effectively under critical deadlines with multiple tasks simultaneously, lead change and improve processes.
• Robust communication skills and attention to detail
• Excellent interpersonal, shown written and verbal communication & follow-up skills.
• Proven track record and passion for dissecting/solving problems with a fact based, data driven, rigorous, and creative approach.
• Leads multiple tasks, highly visible projects and timelines with a sense of urgency, ownership and within deadline.

We will be thrilled if you also have:

• 5+ years of related experience
• Bachelors Degree required
• Knowledge of software quality standards, clinical trials process, applicable regulations, software development risks
• Familiarity with standard security certifications such as SOC 1, SOC 2, etc
• Industry certifications a plus

And finally, here are the ways of working that will help you succeed at Signant:

• You enjoy problem-solving and have a constructive can-do attitude.
• You're motivated by working in a fast-growing global company.
• You’re self-driven, active, and want to learn new things continuously.

We know that everyone has different wants and needs, which is why along with a highly competitive base salary, we support our people and their loved ones with a variety of perks and benefits.
As part of our team, some of the benefits you can expect to receive are:

• Our Long-Term Incentive Plan, which is unique to the industry
• The flexibility to work remotely
• Comprehensive health, dental, and vision insurance
• A competitive retirement savings plan
• Generous paid time off

Does this sound like something you’d like to explore? Then we’d love to hear from you!

Please apply below. We review and respond to every application, keep an eye on your inbox for our reply.

Please note that Signant does not accept unsolicited resumes from Third Party vendors.

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