Job DescriptionThe
Senior Mgr, Quality Assurance provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with the applicable regulations such as: FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards.
This role is accountable for end-to-end Quality oversight across the manufacturing process of Surgery products. The position supports and oversight contamination control strategy, risk-based decision-making, and sustainable compliance culture, while enabling operational excellence and supply continuity.
The Sr Mgr acts as a key member of the site quality leadership team, driving quality strategy, regulatory readiness, and continuous improvement initiatives aligned with global and site objectives.
Works collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross-functional teams.
Job Responsibilities:Operations Quality Oversight- Ensure adherence to cGMP requirements (21 CFR 210/211, 820 as applicable), EU GMP, and ISO standards.
- Provide independent Quality oversight of manufacturing operations, including:
- In-process controls and testing
- Batch record review and approval
- Ensure timely disposition decisions based on sound risk assessment and regulatory requirements.
- Drive increased Quality presence on the shop floor to ensure real-time compliance and issue resolution.
- Ensure production and process controls are aligned with validated states and lifecycle requirements.
- Ensure all investigations, CAPA, deviations, change control, complaints, in your area of responsibility are effectively implemented, sustainable, and inspection-ready.
- Maintain proactive and effective communication with R&D, Design, Regulatory Affairs, and Pharma stakeholders.
Compliance, Risk Management & Continuous Improvement- Drive risk-based decision-making using quality risk management principles.
- Analyze trends across investigations, complaints, and process performance to identify systemic issues and drive improvements.
- Leads the development and documentation of structured, data-driven analyses to support root cause identification, decision-making, and continuous improvement initiatives.
- Serves as the QA Subject Matter Expert (SME) during internal and external regulatory inspections, ensuring accurate representation of quality systems and compliance posture.
- Ensure effectiveness of CAPAs through robust verification of effectiveness (VoE).
- Defines and anticipates data requirements, including non-standard datasets, and ensures the collection of robust, high-quality data to support the evaluation of complex issues and operational challenges.
- Leverages hypothesis-driven analysis and deep understanding of cause-and-effect relationships to evaluate complex processes, identify trends, and interpret data patterns.
- Serves as a Subject Matter Expert (SME) in leading and documenting comprehensive, data-driven situational analyses to support strategic decision-making, regulatory compliance, and continuous improvement initiatives.
Leadership & Talent Development- Lead, coach, and develop a high-performing QA organization, ensuring appropriate capability across operations and quality systems.
- Establish clear accountability, drive ownership, urgency, and execution discipline across the team.
- Develop succession plans and ensure organizational readiness to sustain compliance.
- Foster a culture of quality, transparency, and continuous improvement.
Business & Strategic Contribution- Act as a key contributor to the quality site leadership team, aligning quality strategy with business objectives.
- Manage departmental budget, resources, and priorities to ensure effective deployment aligned with business needs and compliance risks.
Education and Experience:- Bachelor's degree in Engineering or Science. (Master's Degree preferred).
- Minimum 10+ years of experience in Quality within pharmaceutical and/or medical device manufacturing. (Pharmaceutical experience strongly preferred).
- Minimum 5+ years in leadership roles with direct people management responsibility.
- Strong experience with FDA inspections and regulatory interactions (e.g., 483s, Warning Letters).
Knowledge and Skills:Experience in interface with Domestic (US) and Foreign (OUS) regulatory agencies
- Knowledge of cGMP (21 CFR 210/211), QSR (21 CFR 820), EU GMP, and ISO 13485.
- Demonstrated ability to lead through complexity and regulatory pressure.
- Strong data analysis and risk-based decision-making skills.
- Proven leadership skills with focus on accountability, urgency, and execution.
- Experience with Lean/Six Sigma and continuous improvement methodologies preferred.
- Proficiency in SAP and quality systems tools.
Physical Demands: • Must be able to lift, push/pull, and carry up to 25 pounds
• Must be able to wear appropriate personal protective equipment as required
• Position requires sitting or standing for long hours.
Work Environment:Manufacturing and controlled environments (including cleanroom).
Primary Work LocationUSA TX - El Paso - Northwestern Dr.
Additional LocationsWork Shift 
