QA Operations Site Compliance Manager

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 Pfizer’s 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 associate's 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 recom