Director, Digital Audit, Inspection & Continuous Improvement

Biopharma Careers; New York (NY); Hybrid; USD 177,000 - 294,000; Full time

Job summary

Pfizer is seeking a Director, Digital Audit, Inspection & Continuous Improvement to lead CGRC services across Digital lines. You will partner with senior leaders to develop and implement a comprehensive compliance strategy, establish proactive controls, and close audit gaps.

You will champion continuous improvement of global compliance processes and drive remediation actions as needed. The role reports to senior leadership, manages a team, and collaborates with internal CGRC operations and

Qualifications

• Bachelor's degree or higher in a relevant field
• 8+ years of experience in pharmaceutical or biotech IT initiatives
• Experience navigating a highly matrixed organization to drive key initiatives
• Excellent communication, able to succinctly define problems and propose options
• Experience implementing controls aligned to regulatory compliance and pharma regs
• Strong understanding of GMP, GxP, SOX, and privacy/cybersecurity laws
• Excellent stakeholder management and organizational skills
• Ability to work independently and manage multiple priorities
• Experience in an agile work environment with collaborative mindset and proactive problem solving
• Demonstrated leadership across diverse teams and ability to coach others

Responsibilities

• Provide guidance aligned to strategies, regulations, and technologies
• Ensure technology compliance with regulatory requirements (GxP, SOX, Privacy, Security, SDLC)
• Develop and manage a repeatable compliance strategy for Digital initiatives
• Manage risks with senior leadership acceptance as appropriate
• Define governance frameworks and operating models for risk decisions
• Influence VP-level and executive stakeholders to achieve compliance outcomes
• Lead transformation and capability development in CGRC
• Implement metrics and reports to drive compliance improvements across Digital lines
• Offer CGRC consultancy on regulatory compliance for technology solutions
• Align CGRC strategies with organizational technology goals
• Support audits, inspections, remediation actions, and continuous improvement
• Coordinate with Digital leadership to meet CGRC engagement models
• Oversee budget estimation for CGRC portfolio within Digital lines
• Coach and guide teams to improve process effectiveness and control execution
• Support multiple compliance projects concurrently
• Conduct compliance investigations as needed

Skills

Communication skills

Independent worker

Agile experience

Leadership

Regulatory compliance knowledge

Education

Bachelor's degree

Job description

ROLE SUMMARY

Our Global Cybersecurity Governance, Risk Management, and Compliance (CGRC) team provides comprehensive blueprints for cybersecurity excellence by embedding governance, CGRC, and compliance into every layer. The team is responsible for ensuring risk-based decision-making is used and that security, privacy, regulatory compliance and continuous improvement is integrated seamlessly with Pfizer’s organization.

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

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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. This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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