Supervisor, Quality Operations

Responsibilities

• Quality Execution
• Lead daily review and disposition activities across manufacturing operations, ensuring batch documentation accuracy, data integrity, and compliance with established quality standards.
• Utilize AI-enabled review tools to accelerate record assessment, identify anomalies, prioritize risk, and improve decision consistency while maintaining accountability for final quality determinations, cycle-time performance, and regulatory readiness.
• Direct investigations related to deviations, excursions, nonconformances, and quality events, ensuring timely containment, root cause identification, and effective resolution.
• Leverage AI-supported analytics to uncover trends, strengthen investigative rigor, improve documentation quality, and accelerate issue resolution while ensuring actions align with regulatory expectations, operational priorities, and patient safety requirements.
• Oversee lot disposition activities and release workflows to ensure products meet quality requirements before distribution.
• Apply data-driven and AI-assisted insights to evaluate risk, streamline review processes, and improve release efficiency while maintaining compliance, protecting product quality, and supporting reliable supply within a rapidly scaling manufacturing environment.
• CAPA Governance
• Supervise corrective and preventive action processes from initiation through effectiveness verification, ensuring sustainable solutions address underlying causes.
• Use AI-driven pattern recognition and trend analysis to identify recurring issues, strengthen preventive strategies, improve execution quality, and support continuous improvement initiatives that enhance operational performance and compliance outcomes.
• Change Control
• Review and approve quality-related changes, ensuring appropriate risk assessment, stakeholder alignment, and regulatory compliance.
• Leverage AI-enhanced knowledge management tools to evaluate historical outcomes, identify potential impacts, and support informed decision-making while maintaining control, consistency, and effectiveness across quality systems and manufacturing processes.
• Compliance Monitoring
• Maintain oversight of cGMP adherence, procedural compliance, and quality system effectiveness across assigned operations.
• Utilize AI-enabled monitoring capabilities to identify emerging risks, prioritize corrective actions, and improve visibility into compliance performance while supporting inspection readiness, audit preparedness, and sustained operational excellence.
• People Leadership
• Lead, coach, and develop quality professionals through performance management, training, and cross-functional collaboration.
• Foster a high-accountability culture where AI tools enhance productivity, learning, and decision support while employees strengthen technical expertise, problem-solving capabilities, and ownership of quality outcomes in a highly regulated environment.
• Create opportunities for growth, knowledge sharing, and capability development while leveraging technology and AI to increase effectiveness, scalability, and organizational impact.
• Cross Functional
• Partner closely with Manufacturing, Validation, Engineering, Laboratory, and Regulatory teams to resolve issues, improve processes, and drive business objectives.
• Utilize AI-supported collaboration and data-sharing tools to accelerate decisions, improve communication quality, and strengthen alignment across functions while maintaining quality-first outcomes.
• Continuous Improvement
• Identify opportunities to improve workflows, eliminate inefficiencies, and strengthen quality performance across operations.
• Apply AI-enabled analytics, automation, and process intelligence to accelerate cycle times, improve consistency, reduce manual effort, and enhance overall effectiveness while preserving compliance and quality standards.
• Risk Management
• Drive proactive risk identification, assessment, and mitigation activities across quality operations.
• Utilize predictive analytics and AI-assisted trend monitoring to detect emerging concerns, prioritize actions, and support informed decision-making that reduces operational risk, protects product quality, and strengthens regulatory confidence.
• Inspection Readiness
• Ensure continuous preparedness for internal audits, customer assessments, and regulatory inspections through disciplined execution and documentation practices.
• Leverage AI-powered knowledge retrieval, compliance monitoring, and trend analysis tools to strengthen readiness, improve response quality, and support successful inspection outcomes within a hyper-growth environment.

Qualifications

• Minimum of 3 years of experience in pharmaceutical quality, including 2 years in a supervisory role.
• Bachelor of Science degree in a technical or scientific discipline.
• American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or an equivalent certification preferred.
• Possesses knowledge of pharmaceutical manufacturing, United States Pharmacopeia , cGMP, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.

Key Competencies

• Customer Focus: Builds trust through customer-centric solutions.
• Strategic AI: Guides responsible AI adoption and adaptation.
• Optimizes Work Processes: Drives efficiency with continuous improvement.
• Collaborates: Partners effectively to achieve shared goals.
• Resourcefulness: Secures and deploys resources efficiently.
• Manages Complexity: Simplifies and solves complex challenges.
• Ensures Accountability: Delivers on commitments with integrity.
• Situational Adaptability: Adjusts approach to shifting conditions.
• Communicates Effectively: Tailors messages to diverse audiences.

Employee Benefits, Health and Wellness

• We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications.

Physical Requirements

• While performing the responsibilities of the job, the employee is required to talk and hear.
• The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices.
• Employees are regularly required to move about the office and around the corporate campus.
• The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.