Manager, Manufacturing Quality Assurance and Environmental Monitoring

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

HERE IS WHAT YOU NEED (Minimum 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.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• 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.

PHYSICAL/MENTAL REQUIREMENTS

• Must not have a Penicillin allergy.

• The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions.

• Minimal travel for training/seminars.

Work Location Assignment: Onsite

The annual base salary for this position ranges from $106 000,00 to $176 600,00. 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Quality Assurance and Control