QA Operations Site Compliance Manager

St. Louis, MO - USA

Monthly Salary: $ 96300 - 160500

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Use Your Power for Purpose

Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible innovative and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development maintenance compliance or analysis through research programs your contribution directly impacts patients.

What You Will Achieve

In your role you have the all-important task of preparation and review of required procedures documentation and retention practices supporting inspections and supporting ongoing continuous improvement and compliance efforts. You will be relied on to support globally across PharmSci partner lines and Pfizer Global Supply to align goals and support the implementation of effective quality system solutions. Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.

As a Manager your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for Pfizers customers and patients to receive the medicines they need when they need them.

How You Will Achieve It

In this role you will:

Maintain site inspection readiness at all times for the St. Louis site.
Manage the execution of audits by both internal and external auditing groups (corporate regulatory etc.) for the St. Louis site.
Act as primary point of contact for the coordination and execution of all audits and inspections of the St. Louis site.
Ensure the compliance status of all GMP activities at the site and prepare store and distribute regulatory notifications (GMP Attestations Regulatory Inspection History etc.)
Facilitate implementation of global audit/inspection management systems at the local level and provide input into system development.
Represent PSOQ on the St. Louis Site Council as needed.
Partner with PharmSci business lines in the development implementation and management of their procedures documentation and records.
Support the management of Active libraries and other documentation systems (e.g. Document Long Term Storage) for PharmSci to ensure adequate control of physical and electronic records
Review SOPs determine gaps and provide input as it relates to GMP status and inspection readiness.
Provide Global Document Management System (GDMS) Subject Matter Expertise to global and site customers.
Provide document technical writing editing and design support to other team members and supported site departments.

Here Is What You Need (Minimum Requirements)

BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associates degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
Substantial experience in pharmaceutical manufacturing and quality control
Mastery with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
Strong critical thinking skills and a proactive approach
Ability to collaborate effectively manage relationships and communicate well both in writing and verbally
Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM Quality Tracking System Trackwise and Documentum platforms

Bonus Points If You Have (Preferred Requirements)

Experience in Quality Systems in pharmaceutical medical device or combination product industry
Knowledge or exposure to data science
Strong leadership and team management skills
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
Experience in conducting internal audits and supporting regulatory inspections

PHYSICAL/MENTAL REQUIREMENTS

Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus communication 1:1 and with larger groups). Ability to independently problem solve and make recommendations for solutions. Role is primarily office-sitting standing walking and bending. This may be inclusive of leading/participating in video conferences.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Limited travel required (< 25%)

OTHER JOB DETAILS

Last Date to Apply for Job: 10/23/25

Work Location Assignment:On Premise

The annual base salary for this position ranges from $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

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

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. This position requires permanent work authorization in the United States.

Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email . This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control

Required Experience:

Manager

Use Your Power for PurposeEvery day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible innovative and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development maintenance complian...