Dir, It Compliance Jobs

Description

Director, IT Compliance

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®.

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

Why Syneos Health

• 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 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 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 quality and compliance activities within the Information Technology (IT) department with primary focus on representing all aspects of IT at audits and vendor assessments. Reviews computer systems and processes for alignment with departmental Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) guidance and applicable clinical regulations including FDA 21 CFR part 11.

JOB RESPONSIBILTIES

• Administrate the compliance program in accordance with the changing regulatory and industry standards.

• Primary IT contact for the conduct of internal and external audits. Lead hosting of customer audits and regulatory inspections and include other IT subject matter experts as required.

• Prepare for and support customer and regulatory audits as it pertains to Computer Systems Validation and associated topics.

• Presents overview of IT department to visiting auditors and performs as the Subject Matter Expert for IT System Development Life Cycle, Computer System Validation and Departmental regulatory and procedural compliance.

• Responsible for reviewing audit reports specifically in the area of IT Compliance.

• Coordinates the IT audit response across the IT departments in collaboration with Corporate Quality.

• Assist in the creation, implementation, and assignment of IT CAPAs and Quality Issues (QI) generated from audit findings and manages follow-up activities to ensure timely closure of CAPAs and QIs assigned to the IT department.

• Plan and provides strategies for assessing readiness of Syneos Health offices for potential Regulatory Inspections and conducts such assessments within IT.

• Proposes strategies for improvements to quality and compliance operations and services.

• Maintain oversight of Company’s clinical IT system’s compliance status and maintain supporting key matrices.

• Coach and train company personnel in compliance quality-related matters.

• Provide strategic recommendations in regulatory compliance for the Information Technology portfolio.

• Provide inspection readiness training to staff.

• Coordinate training on departmental SOPs and collaborates with the Global Training team on the development and update of IT related training curriculums and certifications.

• Provide input to IT compliance processes, procedures and activities based upon feedback outcomes from audits and assessments.

• Oversee the drafting and revisions of IT departmental SOPs with the appropriate departmental SOP authors and reviews, and manages the SOP documents in alignment and collaboration with Corporate QA to ensure compliance with document controls.

• Conduct reviews of IT procedures to ensure departmental practices are consistent with SOPs, regulatory guidance and industry best practices.

Qualifications

QUALIFICATION REQUIREMENTS

• Bachelor's Degree in Computer Science or related science field or equivalent.

• Understanding of current and emerging regulations and impact on technologies.

• Extensive experience in a clinical trials environment and/or working in accordance with FDA and ICH requirements for CSV (including 21 CFR Part 11), including a comprehensive knowledge of GCP regulations and guidelines.

• One or more of the following certifications desired: American Society for Quality (ASQ) Software Quality Engineer, ASQ Pharmaceutical GMP Professional, or equivalent position related professional certification.

• Ability to perform several tasks simultaneously in a dynamic environment in order to meet deadlines.

• Excellent verbal and written communication.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $121,000 to $255,000. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.