Senior Associate, Risk Mgt, Consulting

ROLE SUMMARY

Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region).

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

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

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
- 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

Indicate basic and preferred qualifications:

- Basic Qualifications are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education/licenses/certifications, location, relevant experience, technical and/or other job-related skills. Basic qualifications determine minimum requirements that applicants must possess to be qualified for the role; anyone who does not meet basic qualifications for the role will not be interviewed or eligible for hire.

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 independenctly 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 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