Job Description

Updated: Yesterday
Location: Canada-North America - CAN-Home-Based, Canada
Job ID: 22011081-CAN975

Description

IT Compliance Analyst II

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life\xc2\xae.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we\'re able to create a place where everyone feels like they belong.

JOB SUMMARY

• Responsible for developing, implementing, validating, maintaining, supporting assigned computerized systems in order to ensure that operations are implemented and maintained in a compliant state.

JOB RESPONSIBILITIES

• Liaison with compliance partners (security, regulatory compliance) to ensure adherence with standards and processes throughout the organization
• Make broad recommendations on improving compliance-related processes and/or procedures as it pertains to the IT department and Identify opportunities for ITGC/security compliance control automation and simplification
• Be the main point of contact for IT and assist on all internal and external audit teams where IT inquiry is required
• Ability to influence others and lead/coach other employees to complete required documentation for CAPA/NCR, etc.
• Work collaboratively with Compliance teams to identify and compliance requirements to help meet stakeholder expectations
• Manage and/or coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization\'s compliance requirements and industry regulations
• Provide support for IT portfolios within assigned area, ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon timelines
• Serve as subject matter expert in specialized area to support client and regulatory agency audits and inspections for Business Technology activities
• Assist internal clients with requests and problem resolution
• Monitor activities of assigned IT areas to ensure compliance with internal policies and procedures including monthly, quarterly, and annual account and activity reviews
• Collaborate and understand stakeholders, external partners, and the project team needs and convey them to developers.

+ Passion for increasing quality and driving business value while simultaneously decreasing the effort to get there by identifying manual DevOps processes that can be automated.

+ Possess a bias for action when breaking down complex problems and tackling new technologies.

Qualifications

QUALIFICATION REQUIREMENTS

• Bachelor\'s Degree in Computer Science or related science field or equivalent.
• 3-5 years of quality related professional experience in life science, medical device, or pharmaceutical industry required
• Understanding of current and emerging regulations and impact on technologies
• Effective verbal and written communication

Preferred Qualifications

• Sound knowledge of required processes and industry standards, e.g., GAMP 5, CFR, Reg 21, Part 11, etc.
• Familiarity with common compliance standards (SOX, SOC2, PCI-DSS, GDPR e and/or ISO 27001.)
• Working understanding of how compliance works with cloud-native technology stacks

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Syneos Health