ROLE SUMMARY

The Director, Digital Audit, Inspection & Continuous Improvement role will be responsible for implementation and execution of the full range of CGRC services to Digital lines, partner with senior leaders of the organizations and engage with their leadership teams to develop and implement a comprehensive compliance strategy based on risk.  The role will also serve as the point of accountability to ensure that appropriate proactive controls are established to manage risk and develop and implement remediation strategies to close any audit and inspection gaps. In addition, this role will serve as the champion for Creation Centers to ensure continuous improvement of global and division specific compliance processes and to ensure that the processes are efficient, straightforward and robust. This role supports audits and inspections directly and indirectly along with remediation actions and projects. 

This position has direct reports.  

ROLE RESPONSIBILITIES  

This role will have the following primary responsibilities: 

• Provides guidance and direction aligned to existing or new developing strategies, regulations and technologies. 

• Accountable for the development, management, execution, and strategy for ensuring technology compliance with or demonstration of controls to manage overall Regulatory Compliance and Pfizer Policy requirements (e.g., GxP, SOX, Privacy, Security, SDLC, etc.). 

• Accountable for the development, implementation, and management of a repeatable Compliance strategy, solutions, services, and standards for initiatives within Digital and related technology areas supported by this role. 

• Works to ensure all customer activities address Regulatory, Privacy, Quality Standards and Security Risks.  Manages risks of activities with senior management acceptance as appropriate. 

• Defines governance frameworks and operating models and drive organizational risk decisions. 

• Accountable for Enterprise compliance outcomes and able to influence VP-level and executive stakeholders 

• Leads transformation and capability development 

• In coordination with internal CGRC operations and the Digital Line organizations, identify and implement Performance Indicators, metrics and standard reports to drive compliance improvements.  Report routinely to Digital lines and Quality on the state of compliance.   

• Provides CGRC consultancy and expertise to colleagues regarding regulatory compliance for technology solutions. 

• Provides strategic and operational CGRC consultancy to support implementation of technology. 

• Align CGRC strategies to the strategic direction and operational needs related to technology implementation. 

• In support of the development and delivery of Digital services and Digital supported solutions, provide risk management direction, compliance event management, periodic review, inspection readiness, and all other CGRC activities as needed in accordance with the Digital Process Framework.   

• Meet with respective Digital line leadership as presented in the CGRC engagement model; Attend program/project team meetings and engage with Senior Leadership in Digital, thebusiness lines, and external partners 

• Manage customer demand for CGRC services and performance of managed service provider for assigned Digital lines as required. 

• Drive the CGRC strategies to support the business model with internal and external processes. 

• Partner with Digital lines in projects representing compliance controls and risk management practices to effectively provide visibility to risks and regulatory requirements that must be addressed. 

• Participate in annual budget estimation for the required portfolio within assigned Digital lines. 

• Support operational activities including Solution Profiles, Compliance Event Management and Periodic Review deliverables, as required. 

• Assure audit and inspection awareness and preparedness and provide coaching and guidance as a compliance expert. 

• Interacts with auditors and inspectors as needed. 

• Support audits and inspections of Digital and technology (prior, during, and post); Work with Digital, business and external partners on the remediation of commitments and tracking of status 

• Continuously work to automate and simplify Digital and technology processes for streamlined impact. 

• Lead assigned CGRC efforts to address compliance gaps, conduct risk assessments and define and implement remediation plans. 

• Support the monitoring of Digital process execution to identify targeted continuous improvement efforts to improve operational process effectiveness and control execution. 

• Based upon monitoring of Digital process execution, lead targeted continuous improvement efforts to improve operational process effectiveness and control execution. 

• Assist with defined compliance-related strategic projects/initiatives and manage the associated records and activity tracking. 

• Support multiple compliance-related projects and initiatives simultaneously. 

• Conduct compliance investigations, as required. 

BASIC QUALIFICATIONS  

• Bachelor's Degree required in a relevant discipline preferably within Information Security, Information Technology, Computer Science, Engineering or related majors. 

• 8+ years of experience in the pharmaceutical or biotech industries supporting IT initiatives.  

• Experienced with working through a highly matrixed organization to support and drive key initiatives 

• Excellent Communication skills, capable of succinctly defining the problem and delivering options for addressing potential compliance gaps 

• Experience with implementing controls aligned to principles, and concepts of regulatory compliance, and of pharmaceutical regulations  

• Excellent understanding and working experience with compliance guidelines and regulations such as GMP, GxP, SOX regulations, and Domestic/International privacy and cybersecurity laws  

• Excellent stakeholder management skills and organizational skills  

• Ability to work independently and manage multiple priorities. 

• Demonstrated experience in an agile work environment possessing qualities such as a collaborative mindset, adaptability to change, and a proactive problem-solving approach. 

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS 

• Frequently solves complex problems, within and outside own area of expertise and typically as part of a team across functions and divisions. 

• Actively shares knowledge across multiple functions. May establish a system to share knowledge across the organization by shaping knowledge management processes and systems 

• Highly self-aware, quick to establish trust, with a customer first mind set 

• Experience with directly and indirectly managing a team of diverse individuals 

• Highly motivated to learn and ingest knowledge across the digital technology spectrum  

• Highly diverse background in process improvement and deconstructing complex business processes 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel as required by the business (less than 20% domestic and/or international) 

• Work Location Assignment: Must be able to work in assigned Pfizer office 2-3 days per week, or as needed by the business 

• This role is NOT remote 

Work Location Assignment: Hybrid

Relocation assistance may be available based on business needs and/or eligibility.