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RQA Information Systems - Senior IT Auditor

Employer
Pfizer
Location
Tampa, Florida
Start date
Aug 9, 2022

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Discipline
Administration, Accounting, Information Technology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work
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Job Details

Why Patients Need You

Your in-depth knowledge and financial skills will keep our products in production and our innovators innovating. Whether you are part of establishing, coordinating, researching, or administering financial operations, your role is critical to getting our medicines in the hands of the people who need them most, faster and more efficiently than ever before.

What You Will Achieve

As a member of the IT Audit team, you’ll help to conduct independent evaluations of Pfizer’s Information Systems and compliance control processes worldwide to ensure Pfizer’s risks are properly managed. Your team will present the results of audits to senior site and division management, including practical recommendations to address identified risks, requiring strong negotiation and influence skills.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

  • Contribute to the completion of projects and manage own time to meet agreed targets.

  • Understand the fundamental business drivers for Pfizer and make decisions within organization's guidelines and policies.

  • Conduct independent evaluations of Pfizer’s Information Systems and compliance control processes worldwide to ensure Pfizer’s risks are properly managed.

  • Present the results of audits to senior site and division management, including practical recommendations to address identified risks, requiring strong negotiation and influence skills.

  • Actively participate on departmental and/or cross-functional teams addressing internal and external issues that support the department’s operations and strategy.

  • Prepare formal written reports setting forth recommendations for local, division and Corporate management to strengthen and improve operations, as well as identify cost or efficiency savings.

  • Actively participate on departmental and/or cross-functional teams addressing internal and external issues that support the department’s operations and strategy.

  • Conduct reviews of all products of audit work performed by staff (work papers, testing and sampling plans, status reports, draft issues, etc.)

IS GxP Audit

  • Responsible to execute and report on information system, process, and control audits to assess compliance of digital systems and other technologies against regulations and guidelines, in addition to Pfizer standards, integrated with other GxP audit areas
  • Responsible for verification of evidence of completion for required action items resulting from audits
  • Maintains good working knowledge of general IT controls, processes, and industry standard platforms supporting GxP regulated activities
  • Ensures digital audit standards and supporting departmental tools are well calibrated against regulatory expectations and interpretations, and audit outcomes driven to completion, issues escalated, and risks effectively mitigated through design of holistic remediation plans and effective CAPA
  • Incorporates feedback from internal and external industry quality trends to drive currency in audit tools and methods
  • Contributes to continuous improvement programs to enhance audit program, standards or cross functional alignment of risks
  • Measures performance against defined KPIs to deliver a strong audit program
  • Provides subject matter specialist support to RQA colleagues to supplement GxP pillar expertise

Qualifications
Must-Have

  • BS (or equivalent), preferably in information technology, pharmaceutical or natural sciences, or equivalent

  • At least 3+ years relevant experience in digital auditing and quality management

  • Experience auditing information systems and infrastructure in the GxP regulated space

  • Working knowledge of Quality Assurance, Computer Software Assurance (CSA) and risk-based approaches to validation

  • Experiencing scoping and conducting audits over IT general controls domains (information security, change management, computer operations, and system development (including qualification and systems validation)

  • Experience with testing of cloud systems, cloud governance and security models, and interpretation of service organization control (SOC) reports

  • Working knowledge of relevant regulations (e.g., 21 CFR Part 11 electronic records/electronic signatures and EU Annex 11) and guidance (e.g., Data integrity, GAMP, etc.)

  • Experience developing and executing risk models for IT systems, including continuous risk assessment approaches

  • Has proven leadership capabilities and can represent Pfizer in industry conferences and with stakeholders

  • Able to engage correct path for stakeholder engagement

  • Experience evaluating and understanding quality standards or their application

  • Broad knowledge of GxP processes executed locally and associated risk

  • Expert on applicable GxP and computer system regulations

  • Effective verbal and written communications, including active listening and presenting findings and recommendations in a clear and concise manner, and resolving issues that may arise in a professional manner

  • Advanced Microsoft Office Suite Skills

  • Ability to work independently and multi-task effectively

  • Demonstrated skills in analysis and problem-solving

Nice-to-Have

  • Master’s Degree and relevant pharmaceutical experience

  • Certified Information Systems Auditor(CISA) preferred or equivalent

  • Knowledge of Quality Assurance and Quality Management principles, including an understanding of computer system validation practices as they apply to the Life Sciences and Pharmaceutical industry

  • Information Systems Audit and Control Association (ISACA) IT Standards, Guidelines and Procedures for Auditing and Control and Code of Professional Ethics

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Ability to accommodate auditee hours schedule as feasible.

Other Job Details:

  • Last Date to Apply for Job: August 22, 2022
  • Additional Location Information: Tampa, FL; Collegeville, PA; Peapack, NJ; San Jose, Costa Rica; Thessaloniki, Greece; Mumbai, India
  • Work Location Assignment:On Premise

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Finance & Accounting

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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