Pfizer Sr. Manager of New Product Quality in Lake Forest, Illinois
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Please note, there are multiple openings for this position. If you wish to be considered for all positions, you must apply to each separate job IDHospira, a Pfizer company, is the global leader of injectable drugs and infusion technologies, committed to putting patients first by improving access and care worldwide. Supporting the Pfizer Essential Health business unit (formerly Pfizer's Global Established Pharmaceutical (GEP) organization) specifically sterile injectables product, the Sr. Manager of New Product Quality will be responsible for supporting and delivering on assigned programs in the Pfizer Essential Health Sterile Injectable Portfolio. Responsible for quality oversight of the development and enhancement of new and existing assets of the sterile injectable portfolio. As the quality representative responsible for representing Pfizer Global Supply, this individual will be the quality resource assigned to the development teams responsible for the development and commercialization of generic sterile injectable products. Additionally, he or she will, identify development program risks pertinent to quality and compliance, working to resolve risks or liaise with partners in quality to drive resolution/mitigation throughout the entire development lifecycle of a program or asset (product). The development lifecycle is defined as starting with concept and ending with the commercial launch of the product. During the product development lifecycle, they will oversee quality attributes related to characterization, specification development, formulation process definition, identification of critical process parameters and critical quality attributes.Key responsibilities for the role include but are not limited to: technology transfer, execution registration batches, stability, development investigations and identification of CA/PA, supplier and contract manufacturing organization qualification and management during development lifecycle, Pre-Approval Inspection Readiness for both internal and external suppliers, analytical method transfer and risk assessment of both processes and products. This position is located in our north suburban Chicago/Lake Forest, IL location; local candidates only.
Development program core-team member responsible for quality oversight to ensure procedures and specifications for Active Pharmaceutical Ingredient (APIs), excipients, finished products, filters, packaging materials, etc. and their respective suppliers, both internal and external, are in alignment with Pfizer Quality Standards, BoH, ICH, compendia requirements and the regulatory submission for the product.Demonstrated ability to support multiple programs while driving identification and mitigation of quality related development issues.Quality peer-review of regulatory submissions and response to agency inquiries.Ability to clearly articulate areas of concern and communicate in written and verbal means to various levels of management. Excellent written and communication skills required to document and facilitate success within the role.Ability to work in a matrix environment, across lines of management, and use situational leadership to collaborate with functional partners.Develop a task / deliverable outline for molecule with detailed oversight of the following areas at a minimum (Assessment / Remediation / Execution planning / QP process / Test Method Transfer) to drive timely completion and escalate potential delays or missed deliverables to management.*Engaging in team activities to incorporate quality and awareness at all levels ensuring all quality deliverables are timely preventing delays in submissions and / or launches. Responsible to support equipment or manufacturing investigations in support of process improvements.
Minimum of 5 years of experience within the pharmaceutical industry. Experience in R&D and Aseptic manufacturing is preferred.Bachelor's degree in science (biology, biochemistry, chemistry or physical sciences) recommended. Advanced degree in science or business is preferred. Expertise in cGxPs (manufacturing, clinical, laboratory or development), regulatory and board of health requirements.Expertise in product development, technology transfer, method transfer, and aseptic manufacturing technologies and requirements with product launch and, as required, commercial support.PHYSICAL/MENTAL REQUIREMENTS Sitting, typing and viewing a computer monitor for long periods of time. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSInternational and domestic travel necessary to facilitate success within the role. (Travel estimated 10%)Due to global nature of role and international development centers, team meetings may be required outside of normal business hours of 9AM-5PM.
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.
Sr. Manager of New Product Quality Lake Forest, Illinois 1049912-1852