WHY PATIENTS NEED YOU
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.
WHAT YOU WILL ACHIEVE
In this role, you will:
QA for automation projects, including validation, qualification, and change control for automated systems.
Develop, implement, and maintain quality systems and procedures for automation, ensuring compliance with FDA, EU, and other regulatory requirements.
Provide QA expertise in risk assessments, engineering change management, and troubleshooting of automated systems.
Oversee data integrity and cybersecurity compliance for automation systems, collaborating with Engineering and IT.
Drive continuous improvement initiatives for automated processes and quality systems.
Review and approve vendor product technical assessments and site applicability from a QA perspective.
Collaborate with cross-functional teams (Engineering, Manufacturing, MSAT, IT) to ensure robust QA support for automation projects.
Ensure appropriate QA risk assessments and documentation are in place and evaluate the impact of changes to qualified automation systems.
Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations.
Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications.
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.
Substantial experience in pharmaceutical manufacturing and quality control.
Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects.
Knowledge of regulations related to vendor management programs and other industry quality systems.
Strong critical thinking skills and a proactive approach.
Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally.
Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms.
Nice-to-Have
Experience in Quality Systems in pharmaceutical, medical device, or combination product industry.
Knowledge or exposure to data science.
Strong leadership and team management skills.
Ability to work under pressure and meet tight deadlines.
Ability to influence and negotiate with stakeholders.
Experience in conducting internal audits and supporting regulatory inspections.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to manage multiple QA automation projects simultaneously.
Strong communication skills to keep stakeholders informed of progress and issues.
Ability to work independently and collaboratively across functions.
Strong leadership and project management skills.
Commitment to continuous improvement and operational excellence.
OTHER JOB DETAILS
Last Date to Apply for Job: November 11, 2025
Additional Location Information: NO
Eligible for Relocation Package – NO
Secondment 6 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.
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.
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 disabilityrecruitment@pfizer.com. 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.