Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
The qualified candidate will provide oversight and management of Compliance (including but not limited to Regulatory, Inspection Readiness, and Data Integrity), and Quality Systems (including but not limited to Training, Document Management, Disposition/RM Inspections, Change Control, Non-Conformance Management (NCM, Investigations), and Validation.
The position includes people leading, employee development, performance reviews, and establishing training plans. The qualified candidate will help drive department goals, objectives, and prioritization as well as collaborate on network teams to achieve product goals and objectives.
What You Will Achieve
In this role, you will be accountable for:
Accountable for compliance functions such as regulatory, management of the site inspection readiness program, and data integrity leadership
Accountable for Quality Systems such as Training, Document Management, Change Control, Non-Conformance Management (NCM, Investigations), Records Management, and Validation.
Accountable for Disposition/RM Inspections, Quality Agreements, and Licensing.
Accountable for maintaining the IMEx QA Ecosystem certification including PCT, Standard Work and CI
Manages multiple site level and department (QA) level projects/ongoing work activities (independently setting and adhering to timelines, work plans, and deliverables) of moderate to high complexity within a Work Team
Manages and leads people (both with and without direct authority), technological, and financial resources in a Work Team
Actively shares knowledge with others within Work Team through existing knowledge sharing processes/systems
Breadth of technical/functional expertise is focused on and includes proficiency in Chemistry, Biochemistry, Microbiology, or related scientific disciplines with the ability to extrapolate learning across these disciplines to address knowledge gaps
Demonstrates good understanding of pharmaceutical industry knowledge, QA functions, QC Laboratory functions, and has strong understanding of these business operations.
Solves moderately to highly complex problems within the manufacturing and testing environments
Here Is What You Need (Minimum Requirements)
Bachelor’s degree with at least 4 years of experience; OR a master’s degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate’s degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Bonus Points If You Have (Preferred Requirements)
People Manager experience
GMP Pharmaceuticals Manufacturing experience
Drug Substance Regulatory experience
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform mathematical calculations and complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Monday – Thursday, 10 hours/day; some travel may be required.
Work Location Assignment: On Premise
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.