Manager Quality Assurance

ROLE SUMMARY

This position, in the Vaccine Research and Development (VRD) Quality and Compliant Operations (QCO) Quality Standards group, provides quality guidance and oversight to VRD staff that aligns with CFR and EMA guidelines for bioanalytical laboratories and Pfizer quality standards. The incumbent is primarily responsible for providing audit/inspection support, guidance in writing laboratory investigations and managing external partnerships. Efforts should be made to seek and embrace continuous improvement opportunities within VRD with an emphasis on quality and data integrity.

Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Pfizer Values, &  global regulatory guidelines (including cGLP/cGCP/cGMP), GCLP, and environmental guidelines, as appropriate, etc.

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 laboratory investigations, identifying root causes and developing appropriate CAPAs to prevent recurrence.

• Onboards and manages relationships with external laboratories.

• Manage internal QA walkthrough assessments of groups within VRD to ensure continued compliance with Pfizer and industry regulations.

• Review and approve SOPs, Test Methods, validation documentation and reports for compliance with CFR, EMA and VRD SOP requirements as a QCO-Quality reviewer.

• 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.

• Write and revise SOPs as required for this job function. Circulate for review, incorporate/address reviewer comments appropriately and ensure timely approval.

• Escalate issues or potential Quality Events to VRD management in a timely manner.

• 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.

• Satisfactorily completes all cGMP/cGLP/cGCP/GCLP, corporate and safety training in conformance with Departmental requirements. Where applicable, perform job responsibilities in compliance with cGMP/cGLPcGCP/GCLP and all other regulatory agency requirements.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Senior Manager, Quality and Compliant Operations
• VRD staff, scientists, project managers, laboratory managers, senior leadership
• RQA, GLP and GCLP Auditing Function

QUALIFICATIONS

Education and Experience

• BS in a relevant scientific field and a minimum of 8 years of cGMP or GLP/GCLP experience or MS in relevant scientific field and a minimum of 6 years of cGMP or GLP/GCLP experience

• Minimum 2 years of experience participating in authoring/reviewing laboratory investigations and/or managing external laboratories

• Excellent written and oral communication skills

• Excellent analytical abilities and problem solving skills

• Ability to provide leadership, set priorities and be accountable to timelines

Technical Skills Requirements

• Laboratory or manufacturing experience in a regulated industry

• Excellent soft skills, including communication, teamwork and adaptability

• Good record keeping skills and writing abilities

• Working knowledge of various computer software such as word processing, spreadsheet, and database applications

Core Competencies

Competency

Detail

Functional/Technical Skills

Uses technical experience in order to deliver high quality solutions.

Seizes Accountability

Takes responsibility for own work and works diligently to meet deadlines.

Acts Decisively

Uses experience to make educated and timely decisions.  A great deal of this contributor's work may be done unsupervised, so he/she must be counted on to make informed decisions.

Change Agile

Maintains poise and accounts for changes in timelines and requirements; increases process and business foresight.

Peer Relationships

Develop relationships throughout the organization in order to increase business acumen and therefore understand more global processes/solutions. 

Commits to “One Pfizer”

Adheres to critical policies; strives to meet global standards.

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

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control