ManagerTL 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 bachelors degree with at least 4 years ofexperience; OR a masters degree with at least 2 years of experience; ORa PhD with 0 years of experience; OR as associates 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 will be able to frequently resolve issues with a focus on quality risk management. They will have demonstrated skill in developing solutions and will do so with a flexible approach to the development of options.

• Demonstrated strong scientific reasoning and problem solving as well as excellent written and oral communication skills with ability to interact with senior leadership and regulatory agencies.

• Understand the importance of clear and timely communication to direct reports on performance-related matters professional development and critical organizational objectives.

• Fluency in English both speaking and writing

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience particularly in aseptic manufacturing

• Experience with electronic systems including Laboratory Information Management System Application and Products MS Word and MS Excel

• Demonstrated leadership capabilities

• Ability to adapt to a fast-paced and changing environment

Work Location Assignment:On Premise

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