Manager Quality Operations

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
May 16, 2022
Ref
4854547
Required Education
Bachelors Degree
Position Type
Full time

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’s dedicated and highly effective Drug Product QA Lot Release Team. You will evaluate and review Pfizer’s commercial batches of drugs. You will make sure that product and process documents match the specifications. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

This colleagues responsibilities will include working directly with above site Pfizer colleagues and customers, providing leadership/mentorship to the Drug Product lot release team, ensure timely release of conforming Drug Product and completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).

How You Will Achieve It

  • Evaluates data and releases Pfizer produced products that conform to corporate, customer, and regulatory standards.

  • Independently provide Real Time Quality impact assessments and decisions on Drug product issues

    • Ability to handle complex and detailed situations

    • Accurately assess consequences of decisions

    • Accurately assess potential Regulatory impacts

    • Immediately escalate issues with potential market or stability impact

    • Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.

  • Effectively leads/facilitates/participates/completes cross-functional team investigations related to laboratory and/or complaint, and Significant Deviations

  • Utilize tools such as Method 1 and Pfizer Human Factors Program (PHP) tools in the course of the investigations

  • Participate/lead Quality Risk Management (QRM) assessments that gain approval through Site and Area QO Management

  • Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc.…as appropriate

  • Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts

  • Independently review and approval internal documents (Internal Stability Reports, Annual Product Review Reports, Validation Protocols, etc) for responsible products.

  • SME support during Regulatory/Customer/Internal audits including contributions to strategies to successfully respond to auditor concerns

  • Effectively communicate complex technical issues to all levels of Site Leadership

  • Train and mentor other QA colleagues in related job responsibilities

  • Effectively communicate supply status at appropriate meetings including Supply Chain Update and Drug Product Tech Triage (DPTT).

Qualifications

Must-Have

Education:

  • Bachelor of Science Degree in Chemistry, Microbiology, Engineering or other science related discipline

Experience:

  • 5-8 years pharmaceutical and/or medical device experience with a bachelors or 3-6 years with a masters.

  • Quality Assurance/Control experience required along with good knowledge of enterprise systems (SAP, LIMS, QTS)

  • Lot release/disposition and deviation/investigation experience.

  • Proactive approach and strong critical thinking skills

  • Strong collaboration, relationship management, and interpersonal skills

  • Excellent written and verbal communication

Nice-to-Have

  • Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

Physical/Mental Requirements

Office position with time in the production environment.

Consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.

Other Job Details

  • Last Date to Apply: May 27, 2022
  • Eligible for Relocation Package: YES

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

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