Quality Systems Compliance Manager
(Hybrid - Blue Bell, PA)

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?

The Signant Health Quality Team is looking for a highly motivated candidate who is passionate about driving improvement and making a positive impression. We are looking for someone who is self-motivated, proactive, and has a strong desire to succeed. The ideal candidate will have a proven track record of success in driving results and exceeding expectations.

The Manager, Quality Systems Compliance will have oversight to the Deviation (Quality Event, QE) and CAPA Management System. This role will be responsible to support the program infrastructure and ensure robust investigations with root cause analysis, will manage timelines to ensure items are completed on time, will escalate and communicate issues as needed, and will prepare and review metrics to evaluate and identify trends, and work with departments and management on solutions.

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

• Point of contact for the site for Quality Events and related CAPAs
• Oversees, monitors and drives CAPA effectiveness
• Ensure that all Quality Events are documented, investigated and resolved in a timely manner.
• Determine need for escalation of Quality Events
• Oversee the methodology for specific Quality issues with accountability to ensure appropriate and timely mitigation and resolution.
• Works in an electronic QMS tool, and can provide input on design, configuration, drop-down selections, etc.
• Prepares and presents regular updates to stakeholders.
• Assesses current processes in place to manage interdisciplinary Quality issues across the company with the goal to establish a more efficient and standardized approach.
• Interprets government regulations, agency guidelines, and internal policies to assure compliance.
• Consults on development of quality improvements and recommends alternatives.
• Regular presentations to management relating to system challenges assigned, the ability to influence the direction of the business and develop solutions is a requirement.
• Provide Quality Event prioritization guidance to team members
• SME and Back Room/Front Room support for internal/ external audits
• Coach QE facilitators who may need assistance
• Ensure QE and CAPA training to key users of the process is conducted
• Responsible for doing independent reviews as needed
• Review and approve software documentation including test plans, test scripts, and validation protocols.
• Manage the day-to-day needs of employees with respect to quality issues.
• Handle external communication regarding compliance and quality assurance issues.
• Measure and report on compliance activities in a regular forum.
• Monitor and report on Key Performance Indicators (KPI's). Provide this information on a timely basis so that clear future strategy can be mapped and achieved.
• Ensure that commitments are met. Monitor performance against targets.

You’ll need to bring:

• Bachelor’s degree required
• At least five (5) years of Quality experience, including prior GxP experience in pharmaceutical and/or software industries
• Investigation-writing skills including experience using root cause analysis tools
• Knowledge and application of global GxP compliance requirements related to computerized systems, eClinical platforms, and SaMD e.g., FDA 21 CFR Parts 11, 820 EudraLex Volume 4 and applicable annexes; as well as ICH and ISO standards.
• Strong organizational, time-management, analytical and decision-making skills
• Strong verbal and written communication skills, including the ability to positively influence the behavior and performance of staff and to positively impact the decision-making of staff and peers
• Strong training, coaching/mentoring, team building, facilitation, and leadership skills to fully equip/engage staff to accomplish work goals in a fast-paced and changeable work environment
• Experience with electronic QMS tools such as Master Control, Veeva, TrackWise, etc

We will be thrilled if you also have:

• Experience with application of current industry guidance and best practices related to software development, system, study, and data life cycles (GAMP, CSV, CSA, QbD, DibD).
• Ability and willingness to travel domestically and internationally as required
• Ability and willingness to work non-standard business hours as business needs dictate

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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