Pfizer Sr. Change Management Specialist in St. Louis, Missouri
This position is responsible for ensuring change management oversight for the Meridian Medical Technologies (MMT) GMP systems for the manufacture of commercial and/or clinical medical devices/combination product including changes associated/originating at vendors. The Sr. Change Management Specialist (Sr. CMS) ensures that GMP changes are executed efficiently and effectively through managing the creation, evaluation, execution, and closure of GMP changes based on MMT's quality requirements, Pfizer global standards and defined processes. The Sr. Change Management Specialist partners extensively with change owners to ensure there is a complete and robust assessment of the proposed change request. To accomplish this, the incumbent will need to have open dialog with change owners, area managers, and key stakeholders. The scope of this role includes oversight of all changes considered to have GMP and/or validation impact, which will include a variety of functional areas within the site. Individuals will specialize in specific areas of support but expected to cross training and support other areas as needed.
Facilitate MMT Change Control Review Committee meetings:
Maintain routine schedule of meetings, ensure appropriate quorum is represented, and specific individuals are invited as needed [based on agenda]
Call for agenda items, publish agenda and publish meeting minutes and attendance in a timely manner and maintain a GMP such records
Ensure the appropriate change planning is taking place by engaging with MMT stakeholders
Ensure changes are grouped per regulatory/validation strategies
Implement and maintain a process by which MMT can plan GMP changes, which includes but is not limited to a change assessment, stakeholder engagement, priority scoring and a banking process for changes needing future consideration
Assist with Quality System Oversight:
Assist with the creation of clear and concise parent change records to support GMP changes; this includes assisting and coordinating write-up of complex changes or as needed to support MMT.
Assist with the creation of change management action items (child records) needed to support a GMP change
Routinely query the change management system for schedule adherence/performance
Review content and approve interim reports for parent records and associated action items within the Change Management module of Trackwise
Act as designated representative for the Change Control Review Committee, provide change management pre-approvals on behalf of and based on, committee decision
Review and approve child records, as appropriate
Ensure records and action items adhere to MMT procedural requirements
Develop metrics that are designed to communicate the overall health of the Change Management Quality System
Review and interpret metrics (key quality indicators), provide assistance and input to determine action plans needed to maintain or improve the state of compliance in Change Management Quality System
Prepare and present metrics to site leadership team
- Develop, maintain and provide system training to user groups and/or individual users, as needed.
Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering or equivalent discipline.
Minimum five (5) years of experience in a pharmaceutical and/or medical device production environment.
Previous experience working with change management processes or process validation for a medical device and/or pharmaceutical company is required.
Familiarity with U.S. FDA 21 CFR Parts 210, 211, and 820, and/or ISO 13485
Quality and business process knowledge:
Understanding of how the change control process affects, and is affected by, other elements in the Quality Management System.
Ability to identify and recognize how the change control process potentially affects the wider business of the company
Demonstrated ability to communicate and interact with all levels of the organization including management
Strong interpersonal skills to provide training
Individual skills required:
Strong proofreading and technical writing skills, as well as exemplary attention to detail
Strong organizational and prioritization skills
Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
Demonstrated initiative and ability to work independently while handling multiple tasks
Strong computer knowledge (MS Office Suite)
Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
Excellent verbal and written communication skills
Fluent in English both speaking & writing
Project management experience
Experience with preparation and/or facilitation of regulatory inspections (U.S. FDA, EMA, etc.) is preferable.
Strong knowledge and understanding of ISO 13485, ISO 14971, and/or 21 CFR 820
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs.; the noise level in the work environment is usually moderate but may be exposed to loud noise. Specific vision abilities include ability to adjust focus and distinguish colors.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
Last Date to Apply for Job: March 8, 2021
Eligible for Employee Referral Program
Eligible for Relocation Package
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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.
Quality Assurance and Control