ROLE SUMMARY
Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region).
Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.
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.
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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.
- Preferred Qualifications are job-related qualifications that may be indicated in addition to basic qualifications; they are not absolutely required for performance of the job but are desired and further describe the education/skills/experience sought for the position. Preferred qualifications enhance a candidate's ability to perform the job.
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
(not all roles will have physical or mental requirements)
Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity.
Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis
Note: Do not include requirements of the role that are generally applicable to most or all jobs at Pfizer, such as "ability to communicate," "ability to work on teams", "office job involving use of computer", etc.
PHYSICAL/MENTAL REQUIREMENTS
Extensive computer use
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
(not all roles will have non-standard work schedule travel, or environment requirements)
Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.
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.
OTHER INFORMATION
The following information, if applicable, must be manually inserted into the job description for transparency:
- Relocation eligible
- Internal candidate identified
- Eligible for employee referral bonus
- Posting expiration date (if determined)
This can be edited or added after the requisition has been created
OTHER INFORMATION
N/A
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key role(s) that this role will interact with as a regular part of the role responsibilities. Include any external interactions as appropriate.
The primary customer groups and key relationships for this position are Digital Client Partners & Creation Centers.
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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