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. This role requires the individual to demonstrate experience in an agile work environment possessing qualities such as a collaborative mindset, adaptability to change, and a proactive problem-solving approach.
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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:
- Ensure Digital solutions (computer systems) are validated and maintained in a compliant manner in accordance with the Solution Development Life Cycle
- 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
- Applicant must have a Bachelor's degree with three years of relevant experience; OR Master's degree with one year of relevant experience; OR Associate's degree with six years of relevant experience; OR eight years of relevant experience with a high school diploma or equivalent.
- Demonstrated experience in computer systems validation, especially in manufacturing environment
- 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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Work Location Assignment: Hybrid colleagues must be able to work in Pfizer office 2-3 days per week, or as needed by the business to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.
Other Job Details:
- Last day to apply: May 09, 2024
- Alternative locations: Groton, CT; Tampa, FL; Collegeville, PA; Bothell, WA
The annual base salary for this position ranges from $74,900.00 to $124,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
The annual base salary for this position in Tampa, FL ranges from $67,400.00 to $112,300.00.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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