The Senior Manager/Associate Director, QA Investigations and Quality Projects is responsible for leading complex quality investigations, managing deviations and CAPA activities, and driving cross-functional quality projects to timely and compliant completion. This role serves as a key Quality Assurance partner to Operations, Manufacturing, Supply Chain, Quality Control, Regulatory Affairs, and external partners to ensure investigation quality, regulatory compliance, effective root cause analysis, and sustainable corrective and preventive actions.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 - $226,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.