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 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 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.

• Lead 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 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

• BS (or equivalent), preferably in information technology, pharmaceutical or natural sciences, or equivalent
• At least 5+ years relevant experience in digital auditing and quality management
• Certified Information Systems Auditor (CISA) preferred
• Experience auditing information systems and infrastructure in the GxP (GMP, GCP, GLP, etc.,) regulated space
• Comprehensive working knowledge of Quality Assurance, Computer Software Assurance (CSA) and risk-based approaches to validation
• Extensive 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) reports
• Comprehensive 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 approaches
• People management and coaching
• Has proven leadership capabilities and is experienced guiding Senior Associates during the execution of audits.
• 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

• Planningand project management while meeting multiple deadlines.
• Collecting and analyzing complex data, evaluating information, and drawing logical conclusions
• Conducting 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.

• Auditor certification to a recognized professional body preferred
• Membership in at least one relevant professional body, ideally with a formal continuous professional development requirement
• Strategic leadership of Quality or Audit teams (specialized and large teams)
• Pharmaceutical experience a plus
• Experience representing organization or company externally
• Demonstrates experience managing budgets
• Experience contributing to business strategy/projects
• Proven ability to coach/mentor other colleagues with less experience
• Experience managing performance of group and holding team accountable for internal KPIs