Job Type: Full time
ROLE SUMMARYIT Auditor:The IT RQA audit manager is responsible for overseeing and leading the full cycle of an audit, from planning to conclusion, with focus on independent evaluation of the Pfizer global level 2 digital audit strategy across regulated processes and vendors across preclinical, clinical, pharmacovigilance and manufacturing to ensure effective quality assurance oversight in line with regulatory expectations and Pfizer standards.This role acts as a resource and subject matter specialist to the Regulatory Quality Assurance (RQA) audit teams and other quality groups in Pfizer.The digital audit experienced professional also participates on strategic and operations teams within Regulatory Quality Assurance.ROLE RESPONSIBILITIES Digital AuditLead from planning to conclusion, independent evaluations of Pfizer’s GxP Information systems and compliance control processes to ensure Pfizer’s GxP risks are properly managed.Responsible to scope, plan, supervise execution 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. As needed, the manager will also be executing testing.Responsible for verification of evidence of completion for required action items resulting from auditsPresent the results of audits to senior management team, including recommendations to address identified risks, requiring strong negotiation and influence skills.Maintains good working knowledge of general IT controls, processes, and industry standard platforms supporting GxP regulated activitiesEnsures 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 CAPAIncorporates feedback from internal and external industry quality trends to drive currency in audit tools and methodsContributes to continuous improvement programs to enhance audit program, standards, or cross functional alignment of risksMeasures performance against defined KPIs to deliver a strong audit programProvides subject matter specialist support to RQA colleagues to supplement GxP pillar expertiseMust Have: BS (or equivalent), preferably in information technology, pharmaceutical or natural sciences, or equivalentMinimum 5+ years relevant experience in digital auditing and quality managementCertified Information Systems Auditor (CISA) preferredExperience auditing information systems and infrastructure in the GxP (GMP, GCP, GLP, etc.,) regulated spaceComprehensive working knowledge of Quality Assurance, Computer Software Assurance (CSA) and risk-based approaches to validationExtensive experience 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) reportsComprehensive and solid 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 approachesPeople management and coachingHas proven leadership capabilities and is experienced guiding Senior Associates during the execution of audits.Able to engage correct path for stakeholder engagementExperience evaluating and understanding quality standards or their applicationBroad knowledge of GxP processes executed locally and associated riskExpert on applicable GxP and computer system regulationsCandidates should also have solid audit skills in all areas below:Planning and project management while meeting multiple deadlines.Collecting and analyzing complex data, evaluating information, and drawing logical conclusionsConducting testing and reviews of all products of audit work performed by other audit members (work papers, testing, etc.)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.Establishing and maintaining good working relationships with team members, staff, and external stakeholders, working effectively in a professional team environment in a matrixed organization.Nice to Have:Auditor certification to a recognized professional body preferredMembership in at least one relevant professional body, ideally with a formal continuous professional development requirementStrategic leadership of Quality or Audit teams (specialized and large teams)Pharmaceutical experience a plusExperience representing organization or company externallyDemonstrates experience managing budgetsExperience contributing to business strategy/projectsProven ability to coach/mentor other colleagues with less experienceExperience managing performance of group and holding team accountable for internal KPIsNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Some outside hours might be required based on Auditees location.Other Job Details:Last Date to Apply for Job: October 5, 2022Additional Location Information: Collegeville, PA; Groton, CT; New York, NY; Peapack, NJ; Tampa, FL; Mumbai, India; Greece; Costa RicaWork Location Assignment: FlexibleRelocation assistance may be available based on business needs and/or eligibility.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 ActPfizer 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 EligibilityPfizer 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