Sr. Associate, Risk Mgt. Consulting

hace 5 meses

San José, Costa Rica Pfizer A tiempo completo

ROLE SUMMARY:
The Digital Risk Management (DRM) organization works with a global stakeholder community to incorporate legal, regulatory and corporate policy requirements into solutions, services and daily Digital operational activities. DRM strives to make compliance simple and to develop logical, robust and cost-effective compliant processes and services across Digital.

The Senior Associate Risk Management Consulting role will collaborate with Digital partners to ensure Digital services and solutions are planned, designed, deployed, operated, and supported in a manner which meets Digital general controls and regulatory requirements.

The position is an individual contributor role with leadership and engagement with cross functional internal colleagues and external partners (under direct oversight).

ROLE RESPONSIBILITIES

Under direct oversight this role will have the following primary responsibilities:

- Deliver risk management and compliance services to assigned Digital lines
- Guides and supports Digital projects with compliance activities such as Solution Profiles, Compliance Assessments, Requirements and test scripts, Validation plans/protocols and reports.
- Review and approve Solution Development Life Cycle (SDLC- Waterfall/Agile methodology) deliverables or change management deliverables
- Works closely with Digital Project Manager, Digital global solution teams and collaborates with associated business groups to ensure that Digital systems are developed and managed in accordance with business and regulatory needs.
- Drives consistently high standards by assuring compliance with policies, regulations, guidelines and procedures.
- Establishes strong relationships with project teams and project leadership to ensure there is effective collaboration and communication
- Assure audit/inspection awareness and preparedness
- Support audits and inspections of Digital (prior, during, and post); Work with Digital customers on the remediation of audit/inspection commitments and tracking of remediation status
- Support the monitoring of Digital process execution to identify targeted continuous improvement efforts to improve operational process effectiveness and control execution
- Assist with defined compliance strategic projects/initiatives, and manage the associated records and activity tracking
- Support multiple compliance related projects and initiatives simultaneously

BASIC QUALIFICATIONS
- BS required; Information Security, Information Technology, Computer Science, Engineering, Science (Biology, Chemistry, etc.) or related majors preferred
- Excellent oral and written communications.
- Ability to proactively solve complex problems both individually and as part of a team
- 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.

PREFERRED QUALIFICATIONS
- 3+ years of experience in pharmaceutical or other regulated industry preferably with GxP computer system validation experience.
- Experience in cGMP’s and 21 CFR Part 11 in an FDA, MHRA, EMA or other regulated environment.
- Experience working through a highly matrixed organization to support and drive key initiatives.
- Experience with the Microsoft Office suite, basic skills managing SharePoint sites and basic understanding of Visualization and Reporting tools.
- Basic understanding of Agile methodology.

REQUIRED APPTITUDES
- Quick to establish trust and respect
- Action oriented and energetic
- Resourceful and avid Lerner
- Easily make connections
- Effective oral, written, and interpersonal communications skills are required as well as organizational, planning, and administrative abilities and the ability to coordinate multiple complex projects simultaneously

PHYSICAL/MENTAL REQUIREMENTS

Extensive computer use

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Domestic and International travel of 10% (as required).

Work Location Assignment: Flexible

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.

Information & Business Tech

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