Job Description

Why Patients Need You

Develops, directs and leads Quality Oversight of Aseptic Manufacturing operations and QA Inspectors activities at Westport campus for St. Louis Operations. In support of site wide objectives, coordinates floor support activities, ensure manufacturing incidents are recorded in the QTS systems and performs initial quality impact assessment, participates in M1 and approves and validation and XP protocols related to WP Operations. Quality oversight with a focus on of WP productions activities and programs. Provides input as needed on SOPs, Master records, forms, among other documents related to Manufacturing operations

Coordinates quality support of validation related activity and production preparation, operation and record review. Engaged with cross functional teams as needed to support continuous improvement activities. Requires decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on overall quality, site priorities, results and achievements.

What You Will Achieve

* Lead QA Inspectors Supervisors responsible for reviewing and auditing executed batch records to ensure manufacturing of the product adhered to the approved record and in compliance with approved SOPs and cGMPs.

* Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.

* Supports operational excellence and site transformational initiatives

* Assists and supports the WP staff in detecting and solving compliance errors in real time during Manufacturing operations.

* Participates in understanding failures and resulting CAPAs through notice of event reports

* Works closely with Manufacturing, QA Supervisors, Document Control and planning.

* Identify issues that may impact the product and compliance with regulations. Determines batch acceptability for further processing, reject or release

* Works independently, with minimal guidance and under short timelines while maintaining quality work.

* Able to work in a team environment within own team and interdepartmental teams.

* Collects and reports data

* Participates in internal GMP audits and supports customer and regulatory audits.

* Collects, researches and analyzes data

* Provide input and assists in review and editing of SOPs / Master Batch Records as needed.

* Trends data, participates in M1, yellow belt, green belt projects as assigned.

* Analyses and interprets data and draws conclusions

* Presents data information skillfully

* Any other tasks assigned by management.

How You Will Achieve It

* Manage multiple projects and ongoing work activities within the division typically involving cross-functional representatives.

* Manage the specific Inspection preparation plan for key Good Manufacturing Practices {also cGMP} elements etc.

* Provides guidance and coaching to Quality Operations colleagues and provide direction or approval of activities and decisions.

* Provide Quality Assurance expertise to site and external parties as required.

* Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.

* Manage site prioritization and management escalation meetings regarding AQRTs (Area Quality Review Teams).

* Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.

* Prepare departmental budgets and control the departmental cost within the budgets.

* Interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.

* Manage and monitor the audit report distribution process to ensure timely delivery of critical information to key stakeholders and complete regulatory commitments

* Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations, review and approval of product and equipment change controls.

* Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.

Qualifications

Must-Have

* Minimum of a Bachelor of Science Degree in Microbiology, Biology, Chemistry or related Technical Physical Science

* Minimum of five years progressive experience in GMP Pharmaceutical Manufacturing environment.

* Minimum of five years team leader/supervisory experience.

* Knowledgeable of current trends in cGMP Manufacturing standards.

* Knowledge of regulatory compliance requirements for Pharmaceutical/Biological manufacturing/Combination Product/Devices (FDA, EU) preferred.

* Knowledge of device/combination product industry regulations

Nice-to-Have

* Master's degree

* ASQ Certification (QE, CQA, QM)

This 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: March 8, 2021

Eligible for Relocation Package

Eligible for Employee Referral Bonus

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 providers 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