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Sr. Manager, Digital Audits & Inspections

Discussion

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

The Sr. Manager Risk Management Audits & Inspections role will collaborate with Digital partners to ensure Audit and Inspection readiness, related to R&D, Clinical, PGS or Infrastructure. Maintaining, reviewing, and promoting audit readiness material, managing communications and assignments during the execution of and receipts of Audit and Inspection inquiries, presenting to internal and external auditors and Regulatory Agency inspectors and supporting Audit and Inspection remediations through completion in a manner which meets Digital general controls and regulatory requirements.

This position is an individual contributor.

ROLE RESPONSIBILITIES

This role will have the following primary responsibilities:

  • Provide strategic and operational Risk Management consultancy to Digital Lines as required.
  • Ensure Audit & Inspection readiness to align with Digital controls, Pfizer Policies/procedures and regulatory requirements.
  • Provide support and consultancy in support of Audits, Inspections and Assessments with Digital partners and assist with remediation plans and commitments.
  • Development and delivery of Digital services and Digital supported solutions, provide risk management, compliance event management, periodic review oversight, inspection and privacy audit readiness, and all other Risk Management activities as needed in accordance with the Digital Process Framework.
  • Meet with respective Digital lines as required leadership as presented in the Risk Management engagement model; Attend program/project team meetings and engage with Senior Leadership in Digital, the business lines, and external partners.
  • Support multiple compliance related projects and initiatives simultaneously
  • Drive the Risk Management strategies to support the business model with internal and external processes.
  • Deliver risk management and compliance services to assigned Digital lines as required.
  • Participate in routine reporting to assigned Digital lines on the state of compliance and improvement opportunities.
  • Assure compliance requirements are met and approve deviations and CAPAs, where applicable.
  • Assure audit, inspection and assessment awareness and preparedness, and provide coaching/guidance as a compliance expert.
  • Support audits, inspections and assessments of Digital (prior, during, and post); Work with Digital customers on the remediation of commitments and tracking of status.
  • Continuously work to automate and simplify Digital processes to make it easier to get work done.
  • Lead assigned Risk Management efforts to address compliance gaps, conduct risk assessments and define and implement remediation plans
  • In coordination with internal Risk Management operations and the Digital Line organization, identify and implement Key Performance Indicators (KPIs), metrics and standard reports to drive compliance improvements and reduce audit findings.
  • 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.
  • Independently identify broad objectives and proposals for Risk Management projects.
  • Partner with Digital to identify, assess, document and mitigate compliance risk in accordance with the Digital Compliance Risk Framework.
  • Conduct compliance investigations, as required.

BASIC QUALIFICATIONS

  • BS required in a relevant discipline preferably within Information Security, Information Technology, Computer Science, Engineering or related majors.

  • Minimum 10 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.

PREFERRED QUALIFICATIONS

  • Highly self-aware, quick to establish trust, with a customer-first mindset.

  • Ability to work cross functionally.

  • 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

  • Flexible working hours to accommodate global time zones.

  • Periodic travel (both domestic and International) may be required (approximately 5%)


Work Location Assignment: Hybrid


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.



Additional Information

  • In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

  • Please note there is no relocation support available for this position

How to apply

  • Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!


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 disabilityrecruitment@pfizer.com. 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.



To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.


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