Senior Manager, QA Investigations and Operations

Job Description

Provides leadership, management and responsibility for Quality Assurance Investigations and Operational Auditing functions. Ensures all quality-related corrective measures related to investigations, deviations, change controls, CAPAs, and complaints are conducted, documented, and closed in compliance with FDA, cGMP, and company procedures. Provides strong investigation and report writing skills as a lead author of high criticality Quality Assurance reports and investigations. Oversees quality systems, documentation management, and internal audit coordination to ensure data integrity and continuous improvement within Quality Operations.

REQUIREMENTS

SKILLS/KNOWLEDGE AND/OR ABILITIES

• Comprehensive understanding of cGMP regulations and FDA expectations for documentation and investigations
• Demonstrated expertise in deviation investigations, CAPA management, and root cause analysis
• Strong investigation and report writing skills with working knowledge of quality systems, change control, and document control processes
• Experience with audit preparation, management, and follow-up for both internal and regulatory inspections
• Excellent organizational skills and attention to detail in document review and recordkeeping
• Strong analytical and problem-solving abilities with a data-driven approach
• Ability to lead cross-functional teams in investigation and CAPA resolution activities
• Skilled in communication with internal teams, regulatory agencies, and external partners
• Proficiency in use of Quality Management Systems (QMS) and document control software
• Ability to train, coach, and develop personnel in investigation techniques and quality system processes

AUTHORITY

Has the authority to review, approve, and close investigations, deviations, and CAPAs; to ensure documentation accuracy and compliance with cGMP; and to recommend process improvements across quality systems.

GENERAL RESPONSIBILITIES

• Understand and comply with policies related to Quality Assurance and Quality Systems.
• Maintain current knowledge of applicable regulatory requirements and industry best practices.
• Communicate effectively with management and staff on investigation outcomes and compliance risks.
• Support and promote a culture of quality, accountability, and continuous improvement.

SPECIFIC DUTIES AND TASKS

• Manage and complete various aspects of deviations, investigations, and CAPA systems to ensure timely, thorough documentation and associated corrective measures.
• Lead and conduct root cause analyses using tools such as 5 Whys, Fishbone, or FMEA. Commonly investigate and author various investigation related reports and analysis.
• Write and or review and approve investigation reports, ensuring clarity, accuracy, and regulatory compliance.
• Complete and/or monitor and track CAPA implementation and effectiveness; ensure follow-up verification is completed.
• Coordinate complaint investigations and ensure accurate documentation and trending of results.
• Oversee quality documentation systems, including controlled document creation, revision, and archival.
• Serve as QA lead for change control review and approval processes.
• Manage and/or assist in internal audit programs and support external audit and regulatory inspection readiness.
• Analyze quality data and metrics to identify trends and recommend preventive actions.
• Ensure timely writing, reporting and closure of investigations to meet internal and regulatory timelines.
• Assist in training and support QA and operational personnel in investigation procedures and documentation standards.
• Assist and collaborate with Manufacturing, Quality Control, and Regulatory Affairs to maintain QA system effectiveness and compliance.
• Support continuous improvement initiatives in documentation, data integrity, and administrative processes.
• Perform other duties as assigned to support QA management and organizational goals.

OTHER CRITERIA

• Apply sound judgment and ethical decision-making in all activities.
• Demonstrate initiative and accountability in completing assignments.
• Maintain awareness of company policies and ensure compliance.
• Promote teamwork and cooperation across departments.
• Perform additional tasks as required or assigned.

SPECIAL SPECIFIC DUTIES

• QA review and approval for:
• Investigation reports (deviations, OOS, complaints)
• CAPA records and effectiveness checks
• Change control documentation
• Controlled documents and SOP revisions

MEASURES OF PERFORMANCE

• Timeliness and quality of investigation writing, closure and CAPA implementation
• Compliance of documentation with internal and regulatory standards
• Effectiveness of QA oversight during active manufacturing operations and related internal audits and inspections
• Accuracy and completeness of quality system records
• Demonstrated improvement in quality system efficiency and compliance metrics
• Positive communication and collaboration across functional teams

REPORTING RELATIONS

Reports to: Director of Quality Assurance

Supervises: QA Supervisors, QA Specialists, QA Reviewers and Quality System Administrators

EDUCATION

• Required: Baccalaureate degree in Chemistry, Pharmacy, Biology, or related scientific discipline
• Preferred: Advanced certification in Quality Management, Quality Auditing, or related field

EXPERIENCE

• Required: 5-8 years of experience in pharmaceutical quality assurance, including investigation and documentation management
• Preferred: 2-5 years of leadership or supervisory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment. Solid-dose manufacturing experience preferred