Senior Manager Quality Assurance – Major Deviations Lifecycle Team
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Lead the Major Deviations Team, ensuring timely, compliant management of significant quality events across manufacturing, packaging, laboratory, and support operations. Provide strategic oversight of deviation investigations, root cause analyses, risk assessments, and corrective and preventive actions to ensure product quality and patient safety. Partner cross-functionally with Quality, Manufacturing, Regulatory Affairs, and other departments to drive robust investigations, continuous improvement, and inspection readiness. Maintain accountability for timely deviation initiation, accurate digital documentation, and effective CAPA execution while supporting internal audits and regulatory inspections. Translate site and business priorities into operational objectives and resource plans to meet FDA and EMA expectations.
Required Qualifications
- Doctorate degree and 2 years of quality support experience
- Master's degree and 6 years of quality support experience
- Bachelor's degree and 8 years of quality support experience
- Associate's degree and 10 years of quality support experience
- High school diploma / GED and 12 years of quality support experience
- Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Desired Qualifications
- Educational background in Life Science and/or Engineering
- Strong understanding of cGMP regulations and FDA, EMA, and global regulatory expectations
- 8+ years of experience in Quality Assurance, Quality Systems, Manufacturing, or Compliance within the pharmaceutical, biotechnology, or another regulated industry
- Strong experience managing major deviations, investigations, CAPAs, and regulatory interactions
- Knowledge of electronic quality systems and data-trending tools with expertise in deviation investigation methodologies and quality risk management principles
- Experience leading and supporting inspection readiness and regulatory audits
- 3+ years of leadership or people management experience with the ability to lead cross-functional teams within a fast-paced, highly regulated environment
- Strong analytical, problem-solving, and decision-making skills
- Solid communication and presentation skills, with the ability to influence stakeholders at multiple organizational levels
- Strong organizational skills, with the ability to manage multiple priorities simultaneously
- Robust leadership capabilities, including strategic thinking, operational execution, team development and coaching, cross-functional collaboration, stakeholder management, a strong quality and compliance mindset, continuous improvement orientation, and sound decision-making under pressure
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