Manager, IT Audit

ROLE SUMMARY

Digital Audit :

The digital audit manager is responsible for overseeing and leading the full cycle of an audit, from planning to conclusion, with a focus on independent evaluation of the Pfizer global level 2 digital audit strategy across regulated processes and vendors across preclinical, laboratory, 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 audit manager is responsible for managing and mentoring a team of 3 auditors on average per audit. In addition, the Digital Audit manager provides oversight of contracted resources, coordination with RQA pillar audit leads, third-party vendors, and key stakeholders in the Digital organization.

The digital audit manager also participates on strategic and operations teams within the Compliance organization.

ROLE RESPONSIBILITIES

Digital Audit

• Lead from planning to conclusion, independent evaluations of Pfizers GxP Information systems and compliance control processes to ensure Pfizers 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 audits.
• Present the audit results to different audiences (e.g., Compliance senior management team, Pfizer Digital, Pfizer Information Management team, Third Party management team, etc.) 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 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 and ensures compliance of Strategic Operations - Digital metrics and defined KPIs to deliver a strong audit program.
• Provides subject matter specialist support to RQA colleagues to supplement GxP pillar expertise.

BASIC QUALIFICATIONS

Candidates should also have solid audit skills in all areas below :

PREFERRED QUALIFICATIONS

Work Location Assignment : On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Finance & Accounting

Locations : IND - Mumbai