Pfizer, S.A. de C.V | Senior Associate, Risk Mgt, Consulting
3 days ago
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Digital takes immense pride in being at the forefront of innovation, harnessing cutting-edge smart technology that profoundly impacts the lives of our patients.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
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 that 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.
Guide and support 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.
Work closely with Digital Project Manager, Digital global solution teams, and collaborate with associated business groups to ensure that Digital systems are developed and managed in accordance with business and regulatory needs.
Drive consistently high standards by assuring compliance with policies, regulations, guidelines, and procedures.
Establish 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.
Demonstrated ability to work in an agile work environment possessing qualities such as a collaborative mindset, adaptability to change, and a proactive problem-solving approach.
QUALIFICATIONS
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.
3+ years of experience in pharmaceutical or other regulated industry preferably with GxP computer system validation experience.
Fluent in Mandarin.
PREFERRED QUALIFICATIONS
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.
Basic understanding of privacy regulations such as China Personal Information Protection Law (PIPL) is an advantage.
REQUIRED APTITUDES
Quick to establish trust and respect.
Action-oriented and energetic.
Resourceful and avid learner.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Domestic and International travel of 10%, as required.
Flexibility to support US and EMEA Timezone when required.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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