Senior Manager/Associate Director, QA Investigations and Quality Projects

Responsibilities:

• Lead, author, review, and approve quality investigations related to deviations/nonconformances, complaints, temperature excursions, audit findings, and other quality events
• Perform structured root cause analysis using appropriate tools such as 5 Whys, Fishbone, Fault Tree Analysis, risk assessment, and process mapping
• Develop and manage CAPA plans that address root cause, reduce recurrence, and include clear owners, timelines, effectiveness checks, and measurable outcomes
• Serve as project manager for quality initiatives, process improvements, remediation activities, inspection readiness efforts, and cross-functional compliance projects
• Coordinate cross-functional investigation teams, ensuring input from subject matter experts is documented, scientifically sound, and aligned with GMP expectations
• Track investigation, CAPA, and project milestones to ensure timely closure, escalation of risks, and transparent communication to Quality and business leadership
• Evaluate product quality impact and support disposition decisions by assessing risk to patient safety, product quality, regulatory compliance, and supply continuity
• Prepare investigation summaries, executive updates, trend reports, metrics, and presentations for management review, client meetings, audits, and regulatory inspections
• Identify recurring quality issues and recommend process improvements, procedural updates, training actions, or system enhancements to improve quality performance
• Partner with internal and external stakeholders to ensure investigation records, CAPA documentation, and quality project deliverables are accurate, complete, and inspection-ready

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong technical writing and investigation documentation skills
• Sound judgment in quality risk assessment and compliance decision-making
• Excellent project management, prioritization, and follow-through
• Ability to influence cross-functional teams without direct authority
• Strong communication skills with the ability to present complex issues clearly to leadership and external stakeholders
• High attention to detail, ownership, accountability, and continuous improvement mindset

Preferred Education and Experience:

• Bachelor’s degree in life sciences, pharmacy, chemistry, engineering, or a related scientific discipline; advanced degree preferred
• Minimum of 7 years of experience in Quality Assurance, Quality Systems, Manufacturing Quality, or related GMP-regulated functions within the pharmaceutical, biotechnology, medical device, or CDMO environment
• At least 5 years of experience leading deviation investigations, CAPA management, root cause analysis, quality risk assessments, and quality event closure
• Strong knowledge of cGMP regulations, FDA expectations, ICH guidance, quality systems, data integrity principles, and inspection readiness practices
• Experience managing cross-functional projects, timelines, deliverables, stakeholder alignment, and escalation of risks or delays
• Proficiency with electronic quality management systems, Microsoft Office applications, project tracking tools, and quality metrics reporting
• Experience supporting regulatory inspections, client audits, internal audits, or inspection response activities
• Certification or formal training in project management, quality auditing, Six Sigma, Lean, ASQ CQE, ASQ CQA, or root cause analysis methodologies
• Experience working with external manufacturing, packaging, laboratory, distribution, or service providers
• Ability to interpret technical data, batch records, procedures, validation documentation, laboratory records, and quality system records