Principal IT Analyst II (Quality Assurance)

Principal BT Analyst II

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.

As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health

* #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.

* We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.

* 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.

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 are in alignment with departmental Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) guidance and applicable clinical regulations including FDA 21 CFR part 11.

Essential Functions:

• Coordinates the IT audit response across the IT departments in collaboration with Corporate Quality Assurance.
• Acts as the primary contact for IT during client and regulatory audits. Presents overview of IT and is the Subject Matter Expert for IT System Development Life Cycle, Computer System Validation and Departmental regulatory and procedural compliance.
• Assists 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.
• Provides input to IT compliance processes, procedures and activities based upon feedback outcomes from audits and assessments.
• Conducts reviews of IT procedures to ensure departmental practices are consistent with SOPs, regulatory guidance and industry best practices.
• Oversees the drafting and revisions of IT departmental SOPs with the appropriate departmental SOP authors and reviewers, and manages the SOP documents in alignment and collaboration with Corporate QA to ensure compliance with document controls.
• Coordinates training on departmental SOPs and collaborates with the Global Training team on the development and update of IT related training curriculums and certifications.

#LI-CK1

Experience

7-10 years in depth experience with clinical regulations pertaining to computer systems validation.

Excellent communication skills, presentation, verbal and written.

Ability to review documentation, synthesize and provide timely responses.

Cross department and functional organizational skills.

5+ years experience with IT general controls a plus

Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated