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Our client is a leading research-based biopharmaceutical company. They apply science and their global resources to deliver innovative therapies that extend and significantly improve lives. Every day, colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
ROLE SUMMARY
The Enterprise Platforms & Security (EP&S) organization delivers the following capabilities for Pfizer. Business application platforms supporting Pfizer’s enterprise application and critical business processes. Infrastructure allowing business traffic to travel where it needs to go, internally and externally, along with the appropriate access controls. EP&S secures Pfizer’s most important information assets through world class controls and protections and enables Pfizer’s business results by making security an enabler and not a roadblock to achieving business results.
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. CRRM strives to make compliance simple and to develop logical, robust and cost-effective compliant processes and services across Digital.
The Manager, 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.
ROLE RESPONSIBILITIES
- Deliver risk management and compliance services to assigned Digital lines
- Partner with assigned Digital lines in projects representing compliance controls and risk management practices to effectively provide visibility to risks and regulatory requirements that must be satisfied
- Liaise with Risk Management managed service provider to ensure Digital Compliance role is being fulfilled for all assigned Digital projects
- Review and approve Solution Development Life Cycle (SDLC- Waterfall/Agile methodology) deliverables or change management deliverables
- Guides and supports Digital projects with compliance activities such as Solution Profiles, Compliance Assessments, Requirements and test scripts, Validation plans/protocols and reports.
- 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
- Lead and mentor junior colleagues through continuous improvement initiatives or project activities
- This role must work in a matrixed environment, and actively practice influencing and negotiation skills to ensure overall compliance by Digital service/solution teams and project teams.
BASIC QUALIFICATIONS
- BS required in a relevant discipline preferably within Information Security, Information Technology, Computer Science, Engineering, Science (Biology, Chemistry, etc.) or related majors preferred
- 5+ years of experience in pharmaceutical or Biotech industry preferably with GxP software development lifecycle validation/verification experience.
- Excellent in-depth understanding and working experience with compliance guidelines and regulations such as cGMP’s and 21 CFR Part 11 in an FDA, MHRA, EMA or other regulated environment
- Experience with GMP process such as investigations, deviations, change control and document management.
- Ability to work on multiple projects concurrently while meeting project and department objectives.
- Ability to make and communicate decisions with limited guidance that may impact project strategy and direction.
- Excellent oral and written communications.
- Ability to work independently and manage multiple priorities
- Experience with Agile methodology
- Experience with paperless testing tools (e.g. ALM-QC, Jira/qTest, etc.)
