About the Role:
Responsible for executing and enhancing quality systems and compliance activities within a GxP-regulated environment. Applies advanced knowledge to perform complex activities and ensure quality systems and processes (e.g., deviations, change control, vendor management, product complaints, document control) are executed in compliance with internal procedures and regulatory requirements.

Contributes to the continuous improvement of the Quality Management System (QMS) by applying advanced GxP knowledge to enhance processes, systems, and data quality. Collaborates cross-functionally, influences stakeholders within scope, supports process oversight activities, analyzes quality data and trends, and serves as a subject matter resource within the functional area.

Your Contributions (include, but are not limited to):

• Independently perform and coordinate complex activities for quality systems and processes, including document control, LMS administration, vendor management and audits, investigations, product complaints, change control, CAPA, SCAR, and deviations
• Ensure accuracy, completeness, and traceability of QA records through oversight of data entry, document processing, record maintenance, and reconciliation activities
• Support and enhance electronic quality systems, including user support, system documentation, and implementation of system or process improvements within assigned functional scope
• Review and process controlled documents and lead the revision and processing of SOPs, work instructions, and other controlled documents to ensure compliance with established standards
• Support inspection and audit readiness activities, including coordination and execution of back room and inspection room support and follow-up activities
• Generate, analyze, and interpret reports, metrics, trackers, and dashboards to support QA performance monitoring, data integrity, and management review
• Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies
• Identify, assess, and escalate quality or compliance issues; support investigations, root cause analysis, and implementation of corrective and preventive actions
• Lead discrete process improvement efforts and contribute to broader continuous improvement initiatives within the functional area
• Provide guidance, coaching, and mentorship to less experienced team members on quality systems, processes, and documentation practices
• Apply sound judgment to resolve complex issues within defined processes and escalate as appropriate
• Perform other QA-related duties, as assigned

Requirements:

• Bachelor's degree from an accredited college or university with emphasis in a relevant field AND 4+ years of relevant experience within the pharmaceutical/biotech industry managing various quality assurance related activities (e.g. training, change control, investigations, systems OR
• Master's Degree AND 2+ years of relevant work experience as noted above
• Strong verbal and written communication skills, with the ability to effectively engage and influence cross-functional stakeholders within scope
• Strong organizational, planning, and prioritization skills, with the ability to manage multiple competing priorities with a high degree of accuracy
• Advanced proficiency with standard computer applications and systems
• Ability to analyze information, apply critical thinking, and exercise sound judgment to resolve complex issues within defined parameters
• Ability to work independently with minimal supervision and collaboratively across teams
• Demonstrated problem-solving and analytical skills, including the ability to evaluate data and identify trends
• Ability to provide guidance and support to less experienced team members
• Strong attention to detail with the ability to balance accuracy with efficiency
• Strong knowledge of quality systems and compliance processes within a GxP-regulated environment (e.g., deviations, CAPA, change control, document control, supplier quality, product complaints)
• Strong understanding of regulatory requirements and industry standards (e.g., FDA, ICH, GxP, GMP, GLP, GCP)
• Experience with electronic quality systems (e.g., QMS, LMS), including system administration, support, and process improvement
• Knowledge of documentation practices, data integrity principles, and requirements for audit and inspection readiness
• Experience supporting audits and inspections, including preparation, coordination, and response support
• Demonstrated ability to identify process improvement opportunities and implement enhancements within functional area
• Demonstrated leadership skills, including leading smaller initiatives and providing mentorship or guidance to junior staff
• Ability to analyze quality data, metrics, and trends to support decision-making and continuous improvement
• Openness to feedback and ability to incorporate guidance

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The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.