The posting
WHY PATIENTS NEED YOU
At Pfizer, our mission is to cultivate a best-in-class culture of continuous improvement and project management, empowering colleagues and streamlining processes. Whether managing projects or collaborating with others, your role in this team is crucial in simplifying and accelerating our work. This enables us to deliver groundbreaking innovations that transform patients' lives. Your contributions will make our operations more efficient and effective, driving us towards achieving our goal of making a significant impact on healthcare. Join us in this mission to inspire excellence and facilitate breakthroughs that truly matter.
WHAT YOU WILL ACHIEVE
This role will coordinate all Quality Management System activities to enable safe, compliant, and predictable shutdown execution and aid to improve site product release attainment. Reporting to the Rochester Site Leader, you will partner across Quality, Manufacturing, Engineering, Maintenance, Validation, Environmental Health and Safety, Supply Chain, Digital, and other site functions to maintain integrated plans, track commitments, identify risks, and provide clear status communication.
HOW YOU WILL ACHIEVE IT
Quality System Project Management
- Build and maintain an integrated quality workplan for shutdown preparation, execution, startup, and closeout, including milestones, dependencies, owners, due dates, and escalation points.
- Coordinate QMS deliverables across workstreams and connect quality activities to the overall shutdown schedule and site priorities. At times, the successful candidate may need to act as RP and execute tasks to fulfill schedule and site requirements.
- Maintain readiness trackers, dashboards, closeout documentation.
- Facilitate quality-focused readiness reviews, daily execution updates, and lessons-learned sessions.
QAR, CAPA, Change Control, and Batch Record Review Support
- Develop, maintain and implement a single site schedule to ensure right-first-time execution and coordination to ensure sequencing of events that most appropriately utilizes site resources to achieve objectives.
- Coordinate and track Quality Assurance Review (QAR) activities associated with shutdown scope, readiness, and return-to-service decisions.
- Support Corrective and Preventive Action (CAPA) planning and by tracking actions, owners, due dates, evidence, effectiveness-check requirements, and overdue risks.
- Support Change Control activities by coordinating impact assessments, approvals, implementation actions, effectiveness requirements, and closure documentation.
- Support deviation, investigation, commitment, and remediation tracking when these activities are linked to shutdown readiness or execution.
- Confirm that quality records and supporting evidence are complete, traceable, appropriately approved, and available for inspection-readiness review.
- Develop concise status reports and dashboards covering milestone health, open actions, aging items, risks, decisions, dependencies, and upcoming deadlines.
- Partner with Quality Operations, Manufacturing, Engineering, Maintenance, Validation, EHS, Supply Chain, Digital, and other stakeholders to align quality-system work with execution needs.
- Promote timely decisions, clear accountability, disciplined follow-through, and proactive escalation across matrixed teams.
- Perform work in accordance with current Good Manufacturing Practices (cGMP), Pfizer Quality Standards, site procedures, data-integrity expectations, and applicable regulatory requirements.
QUALIFICATIONS
Must-Have
- Applicant must have a bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience.
- Experience coordinating multiple activities, deliverables, stakeholders, or workstreams.
- Experience maintaining project schedules, action logs, status reports, risk logs, or project documentation.
- Demonstrated organizational, planning, analytical, and problem-solving skills.
- Ability to work independently within established procedures and escalate issues requiring leadership direction.
- Ability to prioritize competing requirements and complete assignments within established deadlines.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, Teams, and project scheduling or tracking tools.
- Written and verbal communication skills appropriate for coordinating with colleagues, contractors, and site stakeholders.
- Ability to work effectively in a cross-functional and matrixed environment.
PREFERRED QUALIFICATIONS
- Experience supporting shutdowns, turnarounds, production outages, manufacturing operations, maintenance events, or capital projects.
- Experience in pharmaceutical, biotechnology, medical-device, chemical, or another regulated manufacturing environment.
- Working knowledge of current Good Manufacturing Practices.
PHYSICAL/MENTAL REQUIREMENTS
- Ability to sit, stand, and walk for extended periods during shutdown planning and execution.
- Ability to work onsite in manufacturing, engineering, maintenance, office, and project work areas.
- Ability to review detailed project information, schedules, reports, and technical documentation.
- Ability to perform project tracking, schedule analysis, and basic data analysis.
- Ability to wear required personal protective equipment based on the work area.
- The Rochester site is a penicillin manufacturing facility. Candidates must meet applicable site health and safety requirements associated with working in the facility.
OTHER JOB DETAILS
- Last Date to Apply for Job: October 19, 2026
- Additional Location Information: NA
- Eligible for Relocation Package – NO
- Secondment 12 months
- If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
- There will be no change to your current work location.
- Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Continuous Imprv and Proj Mgmt
