Manager/TL Quality Operations – Complaints, Stability and Retains

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.

What You Will Achieve

Leads a team to ensure that the Retains, Stability and Complaint Investigations meet defined quality standards and objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the department and the function.

Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel. Influences corporate policies through partnership with complaint, stability and retain decision-makers, and acts as a resource to network partners, in the areas of complaints, stability and retains.

In this role, you will:

• Lead and manage people, technology, and financial resources within the department, ensuring alignment with short-term goals.

• Actively share knowledge and identify potential improvements in processes or products, taking risks to develop innovative ideas.

• Solve moderately complex problems within the department and assist with issues outside the department when needed.

• Oversee operational activities and manage multiple projects, often involving cross-functional representatives.

• Recognize development needs in others, collaborate on development plans, and manage direct reports through goal setting, coaching, and ongoing assessment.

• Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view.

• Support the Compliance Lead with resource planning, measuring team productivity, and identifying issues or opportunities.

• Ensure inspection readiness by maintaining processes, providing guidance to QC Laboratories, and communicating key learnings from regulatory audits.

• Stay updated on regulatory trends and Pfizer Quality Standards, recommending modifications to procedures and specifications as necessary.

• Collaborate with Pfizer Global Supply groups, maintain vendor service contracts, manage Quality Control Technical Services, and assist in preparing the annual budget.

• Influence to drive outcomes on initiatives with network-level impact, including through negotiation, brainstorming, advocacy, and development of compromise.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years ofexperience; OR a master's degree with at least 2 years of experience; ORa PhD with 0+ years of experience; OR as associate's degree with 8 yearsof experience; OR a high school diploma (or equivalent) and 10 years of
  relevant experience

• Experience in auditing with Good Manufacturing Practices (cGMP) regulated industries

• A successful track record of continuous improvement and the development/implementation of best practices in Quality Operations or manufacturing

• Knowledge of national and international regulations relevant to the production and control of pharmaceutical products and inspection strategy

• Highly motivated, organized, and able to work effectively in a demanding environment with flexibility to changing priorities

• Experience in a cGMP environment, with a strong working knowledge of a variety of pharmaceutical quality systems and processes including analytical testing, quality risk management, deviation and complaint investigation, raw and packaging materials, lot release, manufacturing support, process validation, stability, retains and site compliance related to active pharmaceutical ingredients, liquid / semi solids, injectable products and/or vaccines.

• Demonstrated excellent negotiation skills, and wil