Job Description

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
You will be a member of Pfizer\xe2\x80\x99s dedicated and highly effective quality assurance team. As a member of the team, you will help to establish and maintain an appropriate and sustainable Quality System and Quality Culture in order to ensure compliance with Pfizer and Regulatory Authority expectations. You and your team serve as the primary point of contact for the triage, investigation and resolution of all product quality issues related to U.S. Transport issues and for interacting with the relevant local stakeholders (such as Customer Service, Regulatory Affairs, Medical, BU) and Pfizer Global Supply on such issues. Your role will also monitor the product quality and compliance activities as U.S. Market Quality to ensure current regulatory expectations are met and facilitate internal and regulatory GMP inspections.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

How You Will Achieve It

• Responsible for implementing the Quality Strategy related to Pfizer Quality Standards for the U.S. Transport & Market Quality Assurance team.
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  Line management responsibilities includes resource planning and assignment, process and procedural maintenance, network communications, and colleague development.
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  Maintains the Quality authority and accountability on behalf of Pfizer to those \'real time\' operations activities and parcel disposition status while also providing quality support as U.S. Market Quality for applicable responsibilities (e.g., in-transit temperature excursion inquiries).
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  Partners with U.S. Market Transportation team and internal and external stakeholders in the United States to continually improve quality processes.
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  Provides subject matter expertise on all Quality and Compliance related matters to the Pfizer business teams, logistics service providers, and transportation providers.
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  Provide quality support, audits, and qualification of Pfizer transportation carriers in the United States.
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  Support serialization activities for the U.S. Market including issue resolution with manufacturing sites, process monitoring, audit support, development and maintenance of serialization and product quality processes within Quality, etc.
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  Perform ERP transactions to support operations for the Pfizer business.
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  Review, evaluate and support complex investigations and present formal notifications of significant issues to senior management and Quality Review Teams.
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  Provide close line management, training, motivation and development to Quality professional(s) supporting multiple network locations.
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  Management responsibilities include the provision and monitoring of structured goals, objectives, communications, training, supervision, coaching, feedback and end of year appraisals.
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  Support new product launches and network logistics operations.
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  Provide quality support to special projects related to the Pfizer business or with the transportation carriers.
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  Partner with internal and external colleagues to develop and negotiate quality agreements, standards and contracts.
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  Drive the development, implementation and continuous improvement of Quality Systems to support Pfizer, regulatory and industry requirements.
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  Proactively support regulatory inspections of U.S. Market Transportation, U.S. Logistics Centers (LC), logistics hubs and carrier locations supporting distribution of Pfizer\xe2\x80\x99s products.
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  Ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of CAPA\xe2\x80\x99s within QTS (if required).
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  Provide Quality Leadership for significant deviations at contractor/partner logistics operations that may impact compliance status or require regulatory notifications.
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  Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
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  Prepare ad-hoc S-QRT, routine S-QRT and A-QRT summaries and participate in relevant meetings. Prepare, review and/or issue NtMs as required.
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  Lead quality risk management activities and manage mitigation plans within contract logistic carrier operations.
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  Provide feedback as U.S. Market Quality for applicable PQS and GSOP revisions
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  Accountable for the on-time disposition of commercial products within the logistics network, supporting the Quality Operations network team in line with agreed schedule.
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  Provide Quality leadership for customer complaint investigations associated with logistics operations.
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  Coordinate and communicate progress on scheduled projects.
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  Provides guidance and coaching to Quality Operations colleagues and provide direction or approval of activities and decisions.
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  Provide Quality Assurance expertise to site and external parties as required.
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  Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer\'s standard processes and quality systems.
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  Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.

Qualifications
Must-Have

• Bachelor\'s Degree with 5+ years of relevant experience OR
• Master\'s Degree with 3+ years of relevant experience OR
• Associate\'s Degree with 8+ years of relevant experience OR
• High School Diploma or Equivalent with 10+ years of relevant experience
• Relevant work experience in a current Good Manufacturing Practices (cGMP) environment within the pharmaceutical industry
• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
• Strong collaboration, relationship management, and interpersonal skills
• Strong leadership experience
• Critical thinking skills, excellent writing skills, and good interpersonal communication skills are required. Ability to adapt to constantly changing expectations, parallel objectives, and changing priorities. Must be able to learn quickly, then apply those learnings to the role.
• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, eQMS/TrackWise or equivalent

Nice-to-Have

• Supply chain quality experience
• Knowledge of device/combination product industry regulations

Non-Standard Work Schedule, Travel, or Environment Requirements

• Work Shift: Standard First Shift (M-F) with occasional off-shift work to support business needs/different US time zones
• Occasional business travel required.

Other Job Details:

• Work Location Assignment: Remote
• Last Day to Apply: 01 May 2023

Relocation assistance may be available based on business needs and/or eligibility.






































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\xe2\x80\x99s 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.
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