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
In your role, you have the all-important task of providing Quality Assurance oversight to GMP manufacturing and testing operations for clinical drug substance, intermediates, and starting materials.
This includes quality oversight of technology transfer and disposition deliverables such as review of batch records, investigations, CAPAs, SOPs, test methods, change controls, and release of drug substance, intermediates, and starting materials (e.g. cell banks). In addition to general QA oversight, you will be responsible for driving local implementation of electronic batch records, establishing and maintaining governing procedures, and providing global SME support as electronic batch records are deployed throughout PharmSci. You will be relied on to support globally across PharmSci, partner lines, and Pfizer Global Supply to align goals and support the implementation of effective quality system solutions. Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.
As a Manager, 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 important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It
Represent BTxPharmSci at EBR Site Lead Meetings and offer quality insight for new technologies being developed/implemented
Perform Quality Review and approve Master Template Records including built in properties
Offer Quality support during manufacturing runs and advise on how to fix issues within electronic batch records to stay compliant
Have a thorough understanding of Master Control and how it impacts site quality and compliance requirements
Be the QA point of contact and SME for initial EBR implementations across multiple sites and business lines
Participate in stake holder meetings within Pfizer and with Master Control to contribute ideas to new developments specific to business lines
Have a thorough understanding of quality and compliance standards as it relates to Batch Records
Help develop, review, and approve new batch records within Master Control that support new manufacturing processes
Have a thorough understanding of pharmaceutical manufacturing to ensure batch records and Master Templates are compliant
Participate in discussions and help make decisions of new features from Master Control to implement across BTxPharmSci
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/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs.
Perform quality assurance disposition function for raw materials, in-process solutions, and/or production batches.
Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
Participate on technology transfer teams reviewing and approving master batch records and related documentation.
Support the site relative to a constant state of inspection readiness.
Participate in audits relative to this role as needed.
Make quality decisions to resolve moderately complex issues with minimal assistance from management.
Recognize when an issue is beyond their sphere of influence and escalate immediately.
Present to peers/management locally or electronically.
Contribute to quality assurance management team initiatives and objectives.
Provide review of equipment/instrument validation documentation and related calibration documentation, as needed.
Participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.
Participate in quality risk management activities.
Assist in the process of gathering, interpreting and applying statisticalmethods to various Production/Quality related processes and communicate those through reports, memos, files and presentations.
Assist in the review of area documentation and perform trend analysis on data, controls and standards.
Responsible for knowing, understanding and acting in accordance with Pfizer’s values.
Demonstrate strong interpersonal, teamwork, and collaboration skills.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 4 years ofexperience; OR a master's degree with at least 2 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
Strong understanding of Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
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, Master Control, Trackwise, and Documentum platforms
Bonus Points If You Have (Preferred Requirements)
Extensive 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
PHYSICAL/MENTAL REQUIREMENTS
Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups). Ability to independently problem solve and make recommendations for solutions. Role is primarily office-sitting, standing, walking, and bending. This may be inclusive of leading/participating in video conferences.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None
NO RELOCATION SUPPORT AVAILABLE*
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.