ROLE SUMMARY 

 

The Digital Compliance Manager role will collaborate with other Digital partners and Quality / Risk Management stakeholders to ensure Digital Enterprise Solutions are planned, designed, deployed, operated, and supported in a manner which meets Digital general controls and regulatory requirements. 

In addition, the manager will oversee onshore and offshore contractors.

ROLE RESPONSIBILITIES  

 

This role will have the following primary responsibilities: 

Assist in Enterprise Solution teams’ preparing process and compliance deliverables such as, but not limited to Standard Operating Procedures, Work Instructions, solution profiles; common set requirements, protocols, reports and other compliance deliverables required by regulatory requirements that must be satisfied. Assistance could be through authoring, process review, and oversight as required.  

Lead compliance-related strategic projects/initiatives, and manage the associated records and activity tracking. 

Support multiple compliance-related projects and initiatives simultaneously. 

Assist Enterprise Solution Team’s efforts to address compliance gaps, conduct risk assessments and define and implement remediation plans. 

Conduct compliance investigations, as required and author compliance events documentations, monitoring and closures. 

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

Support audits and inspections of Digital (prior, during, and post); Work with Digital customers on the remediation of commitments and tracking of status 

In coordination Operations, Quality, Technical groups, and other groups, identify and implement Key Performance Indicators (KPIs), metrics and standard reports to drive service improvements. 

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. 

Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve.

BASIC QUALIFICATIONS  

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

Minimum 3-5 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 in-depth understanding and working experience with compliance guidelines and regulations such as SOX, FDA GxP regulations, and Domestic/International privacy laws (i.e. GDPR, PCI DSS, MA201, Safe Harbor, etc.) 

Excellent stakeholder management skills and organizational skills. 

Ability to work independently and manage multiple priorities. 

SAP S4 (On-Premise and Cloud) experience in Access Management, Change Management, and Computer Operations from a Compliance perspective.

PREFERRED QUALIFICATIONS 

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

Highly motivated to learn and ingest knowledge across the digital technology spectrum (preferably SAP Systems)  

Prior experience in risks management focused on controls around IT General Computer Controls.

PHYSICAL/MENTAL REQUIREMENTS 

Manage several competing priorities.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS  

weekend work - as needed, AD Hoc 

travel requirements - less than 5 weeks/year

 
Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & 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, or disability.

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