The Quality Assurance Lead is responsible for ensuring compliance with regulatory requirements and company quality standards. This role involves reviewing and approving manufacturing and validation documents, leading investigations, supporting automation and facility programs, and ensuring the integrity of quality systems. The ideal candidate will possess strong leadership, organizational, and analytical skills, as well as experience in quality assurance processes within a regulated environment.

Key Responsibilities:

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate in incident triage teams as a Quality representative.
• Approve Environmental Characterization reports.
• Oversee the release of sanitary utility systems.
• Approve planned incidents.
• Represent QA in New Product Introduction (NPI) teams.
• Lead investigations and corrective/preventive actions (CAPA).
• Lead and support site audits and regulatory inspections.
• Own and maintain site quality program procedures.
• Act as a designee for the QA Manager on the local Change Control Review Board (CCRB).
• Review and approve Risk Assessments.
• Support automation activities and initiatives.
• Ensure compliance with facilities and environmental programs.
• Review and approve work orders and EMS/BMS alarms.
• Approve non-conformance investigations and CAPA records.
• Manage and approve change controls.
• Provide lot disposition and authorize shipments.

Education & Experience Requirements:

• Doctorate degree OR
• Master’s degree with 3 years of directly related experience OR
• Bachelor’s degree with 5 years of directly related experience OR
• Associate’s degree with 10 years of directly related experience OR
• High school diploma/GED with 12 years of directly related experience.
• Background in Life Science and/or Engineering is preferred.

Preferred Qualifications & Skills:

• Experience using Trackwise for system queries and deviation management.
• Strong knowledge of validation processes and laboratory equipment.
• Ability to manage and approve change controls and deviations.
• Experience in overseeing GMP tasks and ensuring process compliance.
• Strong organizational skills with the ability to complete assignments efficiently.
• Leadership and negotiation skills with the ability to interact effectively with regulatory agencies.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong communication skills (both written and oral).
• Bilingual in English and Spanish preferred.
• Ability to evaluate and address compliance issues effectively.
• High attention to detail with strong analytical and problem-solving skills.