Sr. Quality Specialist (Quality Systems)

Role Summary

Sr. Quality Specialist (Quality Systems) at Pfizer. Responsible for managing day-to-day activities of multiple quality programs or processes, such as change management, document management, deviations, and CAPAs; training staff; ensuring procedural compliance; and implementing program improvements aligned with industry best practices. Must interact with staff at various management levels and present to internal and external customers on specialized aspects of the programs. Expert knowledge of change control process and regulatory impact assessment required.

Responsibilities

• Manage multiple quality processes or programs, including leading discussions with mid- to senior staff on status of key activities and risks
• Assist junior to mid-level staff with performing program assessments and activities
• Own and manage Site Change Review Committee (SCRC) activities
• Develop new business processes and provide training for the process or program
• Process complex records that may involve external parties
• Support audits and inspections as a subject matter expert or other roles
• Assess all change controls to determine potential regulatory impact
• Lead cross-functional projects to successful completion
• Represent site as LPO for Quality Systems (Deviation, CAPA, Change Control)
• Participate as an SME in audits and inspections as needed
• Represent Quality Systems on cross-functional teams or teams with external parties
• Lead continuous improvement activities that may involve a team
• Review staff training assignments
• Make independent decisions within areas of expertise, with management support on complex issues
• Mentor and potentially supervise entry-level associates
• Other duties as assigned

Qualifications

• Minimum: Bachelor's degree with 2+ years of experience; or Master's degree with 0+ years; or Associate's degree with 6 years; or high school diploma (or equivalent) with 8 years relevant experience
• Working knowledge of current industry practices and standards
• Advanced expertise with Office 365, especially Excel
• Experience with applicable software (e.g., Learning Management System, electronic Quality Management System, data analytics)
• Excellent written and verbal communication skills
• Demonstrated problem-solving skills and techniques appropriate to role
• Ability to manage routine and non-routine workload with minimal supervision
• Expertise in Change Control processes and regulatory requirements of change types
• Expertise in deviation/CAPA management processes
• Strong ability to share vision, direction, and data across levels and diverse teams
• Detail-oriented

Skills

• Quality systems and compliance
• Change control and regulatory knowledge
• CAPA and deviation management
• Training and staff development
• Cross-functional collaboration and project leadership
• Data analysis and reporting

Education

• Bachelor's degree required; alternative options as noted in Qualifications (see above)

Additional Requirements

• Non-standard Work Schedule, Travel Or Environment: On-site day shift, Monday – Friday; some exceptions for manufacturing support; some travel may be required but minimal