Hiring company: Pfizer
ROLE SUMMARY
The Inspection Manager will function as the site Subject Matter Expert for all Manual Visual Inspection (MVI) and Automated Inspection (AI) process at the Pfizer St. Louis Site. They will be the Process Centric Team leader for the Inspection PCT.
This position is a people leader role supporting both the Westport and Brentwood manufacturing sites and will ensure robust MVI and AI programs are established for all manufactured products.
It requires management of staff and organized labor (union) colleagues to ensure that the manufacture of products complies with cGMP requirements, labor, yield and material standards are met, and that planned production occurs as scheduled to meet forecasted sales.
ROLE RESPONSIBILITIES
The Inspection Manager will provide the necessary leadership, resources (internal and external) to ensure the success of the MVI and AI programs at the site by establishing strong partnerships with Site Leadership, Operations, Engineering, Validation, Quality, Operational Excellence, etc.
It is expected that the incumbent will develop and maintain a cohesive regulatory inspection readiness program and serve as the SME for MVI and AI processes during regulatory agency inspections to ensure fully compliance with cGMPs.
This position will have responsibility for site projects that will impact the regulatory compliance, reliability and efficiency of the site.
They will be accountable for execution of estimating, planning and development for site capital projects associated with MVI or AI.
The incumbent will provide ownership of site procedures to define documentation of MVI process, as well as procedures for operation, cleaning and maintenance of Automated Inspection systems, in accordance with cGMP practices, Pfizer PQS and CFR21 Part 11.
This role will manage the manual Inspection qualifications of Inspectors and required Quality Assurance personnel to ensure all qualifications are performed within procedural timeframes and in a consistent manner. They will be responsible for the ownership and maintenance of the Inspection Qualification area and all training and qualification activities performed within.
The Inspection Manager will work in a collaborative partnership with the Product Technology group to develop, create and qualify Equipment Challenge kits and MVI Inspector Qualification test kits to ensure challenging of equipment and Inspector MVI qualifications are being performed correctly.
Responsible as site lead for internal or external Defect Tracking Systems.
Cross-functional team leader that can develop strategy and ensure execution across diverse stakeholder groups and possess the ability to provide Senior Leadership level presentations for status, issue escalation and strategy alignment.
BASIC QUALIFICATIONS
Education & Experience: 5+ years with Bachelor’s Degree or 3+ years with Master’s Degree in an accredited program in a relevant Engineering or science discipline. Certificates, Licenses or Registrations: None
- Language Skills: Comprehensive demonstrated skills in communicating effectively with diverse individuals and groups.
- Mathematical Skills: Demonstrated ability to manage and plan budgets.
- Reasoning Ability: Demonstrated problem solving and business decision making.
- Physical Demands: Ability to walk distances & climb stairs
- Work Environment: Use of hearing, eye and gowning protection as required.
PREFERRED QUALIFICATIONS
The individual should have the relevant technical skills associated with Pharmaceutical and Combination Drug Device manufacturing. Prior manufacturing experience strongly preferred.
PHYSICAL/MENTAL REQUIREMENTS
This position Requires:
- Frequent Standing, Walking to access production areas
- Occasional bending, and lifting up to 25 lbs.
- Wearing gowning and personal protective equipment in specific areas.
- General knowledge of good ergonomic practices.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a 1st Shift Position with support to 2nd and 3rd shift production. Job may require occasional weekend/evening work supporting a 24-hour/7-day operation between both Westport and Brentwood facilities.
Position requires regular on-site attendance. This position cannot be performed on a remote or on a telecommute basis.
May require travel to vendors or other Network sites.
Must have the ability to multi-task across multiple capabilities and handle multiple competing priorities, including performing site and functional responsibilities, respond to frequent email and communications. These activities may not be time bound to core hours or presence at the site.
Must be willing to work beyond hours typically defined as a “regular workday”, which may or may not include weekends and holidays
as necessary.
SUPERVISION:
This position will manage (3) Visual Inspection Specialists and (2) Production Supervisors and reporting operational personal under the Inspection Process Centric Team PCT-5
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
Last date to apply for job: November 5, 2021
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.