Sr. Change Management Specialist

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in quality oversight for change control system, product change control oversight with Regulatory Affairs and APR program management. You will also be relied on to support non-manufacturing functions, quality strategic planning, performance metrics and quality goals and objectives. You will also quality provide related oversight for other functions.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Review and interpret metrics, provide assistance and input to determine action plans needed to maintain or improve the state of compliance in Change Management Quality System.
• Perform Risk Assessments for Validation systems.
• Remain up to date on current Regulatory trends as well as Pfizer Quality Standards.
• Conduct product Quality Assurance Professional (QAP) updates in Quality Information system (QIS) system.
• Schedules and manages calibration/maintenance service contracts with outside vendors and maintain calibration database.
• Participate in internal audit program as auditor.
• Support realization of the site self-assessment program by conducting internal audits/ walkthroughs, ensuring the follow-up on corrective/preventive actions, and assisting with Inspection Readiness.
• Participate and contribute on group engagement teams to evaluate and recommend improvements to equipment and general laboratory process
• Assist with the creation of clear and concise parent change records to support Good Manufacturing Practices {also cGMP} changes.

QualificationsMust-Have

• Bachelor's Degree
•  3+ years' experience
• Experience with preparation and/or facilitation of regulatory inspections
• Previous experience working with change management processes or process validation for a medical device and/or pharmaceutical company is required
• Strong interpersonal skills to provide training
• Excellent organizational skills, ability to handle changing deadlines and responsibilities.
• Strong written and verbal communication skills
• Strong computer knowledge (MS Office Suite)

Nice-to-Have

• Master's degree
• Demonstrated ability to learn and master new applications software

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: September 17, 2021

Eligible for Relocation Assistance

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

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