Manager Investigations

Use Your Power for Purpose

In your role, you will help us in investigation of any quality issues in manufacturing and quality laboratories. You will work with a team to investigate deviations and out-of-specification results and atypical result investigations. Your problem-solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. You will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.

What You Will Achieve

In this role, you will:
 

• Manage multiple projects / ongoing work activities within the department typically involving cross-functional representatives.
• Evaluate policies and procedures are developed, maintained in accordance with Corporate and regulatory requirements.
• Collaborate with cross functional teams, perform and document investigations regarding Manufacturing incidents.
• Investigate, identify root cause and preventative measures using DMAIC approach and other appropriate tools.
• Analyze the information using different statistical tools.
• Design studies as needed to gather critical data for investigations and/or corrective actions.
• Coordinate and direct product disposition in accordance to agreed plan with Management.
• Identify and implement corrective and preventive actions (CAPA) to eliminate the potential for non-conformities to occur.
• Perform effectiveness checks for investigations.
• Track, trend and act in a systematic and effective way to assure timely closure.
• Identify opportunities for improvement through investigations; and implement them via simplification projects and quality system tools.
• Provide training and guidance to manufacturing investigators to promote consistency in investigation practices.
• Coach and develop colleagues in investigation skills and provide guidance to team members in critical investigations.
• Develop the team capability and skills through continuous support and one on one coaching.
• Review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected GXP standards.

Here Is What You Need (Minimum Requirements)

• Applicant must have a high school diploma (or equivalent) and 10 years of relevant experience; OR an as associate's degree with 8 years of experience; OR a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience.
• Experience in handling of investigations through Quality Tracking System/Quality Management System.
• GMP Manufacturing and/or QA/QC Laboratory environment experience.
• Project Management experience.
• Strong interpersonal and influential skills.

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience.
• People Management Experience.
• Broad experience and knowledge in all areas of biologic manufacturing, including cell culture, fermentation, purification, microbiology and chemistry.
• Strong understanding of DMAIC methodology and Method 1 coaching training, or similar.

Physical/Mental Requirements

• Able-bodied; must be able to climb flights of stairs and be standing for ~1-2 hours at a time.
• Inspiring – Motivate and develop self and others to drive the business forward
• Courage – Consistently demonstrate accountability and integrity
• Resilience – Respond to change with agility, optimism and innovation
• Decisive – Manage complexity to make timely informed decisions
• Focus – Develop impactful short- and long-term solutions for our customers and patients
• Connected – collaborate with others to accomplish shared goals

Non-Standard Work Schedule, Travel or Environment Requirements

Schedule is 1st shift, Monday - Friday. Occasional off shifts hours and weekends as necessary.

OTHER JOB DETAILS

• Last Date to Apply for Job: June 20, 2025
• Referral Bonus Eligibility: YES
• Eligible for Relocation Package: YES

The annual base salary for this position ranges from $102,900.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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 life’s 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 | (uscandidates.mypfizerbenefits.com). 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.

Quality Assurance and Control

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