Pfizer Change Management Specialist in United States

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.

Provides assistance with change management quality oversight for the MMT GMP systems for the manufacture of commercial medical devices/combination product including Vender changes. Ensures that GMP changes are executed efficiently and effectively through managing the creation, evaluation, execution, and closure of GMP changes based on Pfizer's quality requirements, global standards, and processes. The Change Management specialist partners with change owners to ensure there is a robust dialog and complete vetting process for changes at the site. 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.

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.

Facilitate the site Change Control Review Committee meetings:

  • Maintain a routine schedule of meetings

  • Ensure appropriate quorum is represented

  • Ensure specific individuals are invited as needed

  • Call for agenda items

  • Publish agenda

  • Publish minutes and attendees

  • Maintain a GMP record or repository of agendas and minutes.

Assist with Quality System Oversight:

  • Routinely query the change management system for schedule adherence/ performance

  • Assist with the creation of clear and concise parent change records to support GMP changes

  • Assist with the creation of change management action items (child records) needed to support a GMP change

Decisions/Approvals:

  • Review content and approve interim reports for parent records and associated action items (first IR)

  • Designated representative for the Change Control Review Board, provide change management pre-approvals on behalf of the committee based on committee decision

  • Review and approve child records

Metrics:

  • Prepare metrics to site leadership team

Training:

  • Provides system training to user groups

  • Maintains training materials

  • Provide user training

QUALIFICATIONS

Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.

4 Year degree (BS or BA) in Chemistry, Biology or other related science or engineering field.

Experience with Change Control, GMP compliance, Excel

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.

Standard work environment.

Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

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

(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.

Standard work environment.

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.

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.

The job is open only to Protected Individuals (as defined by 8 U.S.C. ยง 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.

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.

  • Last Date to Apply for Job: May 25, 2018

  • Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.