Qa Manager Jobs

About The Position

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 or equivalent.
• Strong analytical and problem-solving skills.
• Ability to work independently and make decisions.
• Experience in interfacing with regulatory agencies during audits.
• This position requires permanent work authorization in the United States.

Nice To Haves

• Master's degree with a solid understanding of device and combination product industry regulations.
• Excellent organizational and time management skills.
• Ability to drive continuous improvement initiatives.
• Experience using common AI tools, including generative technologies such as 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 procedure.
• Ensure the site has robust quality systems in place for areas such as but not limited to change control, investigations, annual product review, stability and risk management.
• Approve investigations and change control activities, maintaining compliance with configuration management policies and overseeing site prioritization and management escalation meetings.
• Manage the Site Quality Management Review process including facilitating the monthly meeting and managing the charter and plan.
• 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

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