Manager, Manufacturing Quality Assurance and Environmental Monitoring (2nd Shift)

Pfizer • Rochester, MI

19h • Onsite

About The Position

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 designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and 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 who rely on our products. WHAT YOU WILL ACHIEVE 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 provide technical guidance and oversight to team members, fostering a collaborative environment Identify and implement potential improvements in processes or products, taking calculated risks to develop innovative ideas Manage the performance of direct reports through goal setting, coaching, and ongoing assessment, recognizing the need for development and creating development plans Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view, while sharing own perspectives and rationale Evaluate and review clinical and commercial batches of drugs, ensuring compliance with established specifications through rigorous sampling and statistical process control procedures Approve investigations and change control activities, maintaining compliance with configuration management policies and overseeing site prioritization and management escalation meetings Develop and oversee inspection preparation plans for key Good Manufacturing Practices (cGMP) elements, providing Quality Assurance expertise and guidance to colleagues and external parties Prepare departmental budgets, control costs, interface with Regulatory Agencies during audits, and manage audit report distribution to ensure timely delivery of critical information and regulatory commitments

Requirements

• Applicant must have 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; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
• Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry.
• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced.
• Strong collaboration, relationship management, and interpersonal skills.
• Strong people management experience.
• Excellent written and oral communication skills.
• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent.

Nice To Haves

• A solid understanding of device and combination product industry regulations.
• Strong analytical and problem-solving skills.
• Ability to work independently and make decisions.
• Excellent organizational and time management skills.
• Experience in interfacing with regulatory agencies during audits.
• Ability to drive continuous improvement initiatives.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Lead and manage people, technology, and financial resources within the department, ensuring alignment with short-term goals
• Actively share knowledge and provide technical guidance and oversight to team members, fostering a collaborative environment
• Identify and implement potential improvements in processes or products, taking calculated risks to develop innovative ideas
• Manage the performance of direct reports through goal setting, coaching, and ongoing assessment, recognizing the need for development and creating development plans
• Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view, while sharing own perspectives and rationale
• Evaluate and review clinical and commercial batches of drugs, ensuring compliance with established specifications through rigorous sampling and statistical process control procedures
• Approve investigations and change control activities, maintaining compliance with configuration management policies and overseeing site prioritization and management escalation meetings
• Develop and oversee inspection preparation plans for key Good Manufacturing Practices (cGMP) elements, providing Quality Assurance expertise and guidance to colleagues and external parties
• Prepare departmental budgets, control costs, interface with Regulatory Agencies during audits, and manage audit report distribution to ensure timely delivery of critical information and regulatory commitments

Benefits

• 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
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees