Manager, Laboratory Compliance and Data Integrity
Job Description
ROLE SUMMARY
As a member of our Quality, Informatics and Data Operations (QIDO) team, you will provide quality guidance and oversight to Vaccines Research and Development (VRD) colleagues that aligns with CFR and EMA guidelines for bioanalytical laboratories and Pfizer quality standards. You will primarily responsible for providing audit/inspection support, guidance in writing laboratory investigations, documentation review and leading data integrity initiatives. You will also focus on continuous improvement opportunities within VRD with an emphasis on quality and data integrity.
ROLE RESPONSIBILITIES
Manage activities related to regulatory inspections and corporate audits, including audit/inspection readiness, communications, response handling and coordination with other VRD groups.
Review and approve SOPs, Test Methods, validation documentation and reports for compliance with CFR, EMA and VRD SOP requirements as a Quality reviewer.
Review and participate in Data Integrity and compliance assessments of laboratory instruments and software.
Review and approve laboratory investigations, identifying root causes and developing appropriate CAPAs to prevent recurrence.
Escalate issues or potential Quality Events to VRD management in a timely manner.
Provide support across various Quality management processes, including the VRD change control programs.
Foster continuous improvement and develop solutions to address issues, improve processes and quality metrics. Drive projects to completion by proposing solutions, gathering feedback from stakeholders, identifying areas which need escalation and sharing lessons learned.
Maintain strong connections and communications with line SMEs, leading efforts to map the sequential movement of information and data that feed into digital products to ensure data integrity.
Lead efforts across Bio Process R&D group lines to identify gaps and define solution requirements for Digital Products by understanding end user requirements.
Write and revise SOPs as required for this job function. Circulate for review, incorporate/address reviewer comments appropriately and ensure timely approval.
Conduct internal QA walkthrough assessments of groups within VRD to ensure continued compliance with Pfizer and industry regulations.
Maintain and continuously develop knowledge of global GxP regulations and guidelines as they apply to VRD. This knowledge should be used to make quality decisions.
Completes all cGMP/cGLP/cGCP/GCLP, corporate and safety training in conformance with Departmental requirements.
Where applicable, perform job responsibilities in compliance with cGMP/cGLP/cGCP/GCLP and all other regulatory agency requirements.
QUALIFICATIONS
BS in a relevant scientific field and 5+ years of cGMP or GLP/GCLP experience OR
MS in relevant scientific field and 3+ years of cGMP or GLP/GCLP experience
Laboratory or manufacturing experience in a regulated industry
Minimum 2 years of experience participating in audits/inspections and authoring or reviewing laboratory investigations
Excellent written and oral communication skills
Experience with Microsoft Office and data base applications
PHYSICAL/MENTAL REQUIREMENTS
Work primarily performed at individual’s desk, computer workshop, or may require walking around to various laboratories/biosuite.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Weekend work required on occasion, dependent upon high priority project needs
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 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.
