Pfizer Quality Manager, Design Control in United States

ROLE SUMMARY

Provides quality oversight for design control lifecycle activities for the auto injector platforms. Provides Quality input and review for combination product related design projects, quality system records and design control procedural deliverable requirements. Leads and facilitates risk assessment activities and guides design verification and validation plans. Assesses and improves systems, procedures and practices. Approves protocols and reports as needed. Responsible for oversight of Design Control Lifecycle

Responsibilities

  • Provide oversight to the Product Technology team and manufacturing site to ensure compliance with FDA's regulations / guidance documents as well as site SOPs

  • Review/Approve impact assessments for complex/significant CAPA and Change Management records and develop execution plans

  • Facilitate risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed

  • Review and Approve Design History and Risk File documentation

  • Utilize Design History and Risk File documents to assess risk resulting from complex/significant changes, manufacturing events and customer complaints

  • Perform periodic reviews of Design History and Risk File documents to ensure the files remain reflective of data/trending signals and ongoing activities

  • Provide direction and approval for engineering and development documentation

  • Provide guidance and approval for protocols and reports ensuring adherence to design control procedures and policies

  • Provide guidance and oversight for design verification and validation activities.

  • Lead investigations of device failures to determine root cause and work with teams to implement appropriate corrective and preventative actions

  • Provide oversight of new drug delivery system projects to R&D and other technical teams

  • Create test fixtures or components

  • Review/Approve Combination Product technical assessments

  • Represent the Quality Unit during Design Reviews

  • Provide Design Control lifecycle, procedure and policy training as necessary.

  • Identify and correct deficiencies in procedures and practices

BASIC QUALIFICATIONS

  • Bachelor's Degree in Engineering or Science

  • 7-10 Years Experience in medical device or combination product manufacturing within the Quality function

  • At minimum 5 years providing direct oversight to the design control lifecycle and DHF

  • Well versed in ISO13485 and 21CFR820 requirements

  • Critical thinking ability and attention to detail

  • Effective technical writing ability and verbal communication skills

  • Computer skills including MS Office and MiniTab

  • Demonstrated applied knowledge of Failure Modes Effect Analysis (FMEA), CAPA, Root Cause Analysis and statistical methods as applied to Quality.

PREFERRED QUALIFICATIONS

  • Certified Quality Engineer or Six Sigma Black Belt

  • Experience with DHF remediation

PHYSICAL/MENTAL REQUIREMENTS

Able to sit and stand for extended periods of time

Critical thinking and ability to pay attention to detail

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May require work beyond typical business hours

May require travel 0-10%

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.

The job is open only to Protected Individuals (as defined by 8 U.S.C. ยง 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.

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.

Other Job Details:

  • Last Date to Apply for Job: August 30, 2018

  • Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.