Sr. Manager, QA

Summary

The Senior Manager, Quality Assurance leads the execution, maintenance, and ongoing improvement of GxP quality systems and teams that support Phase 2a through Phase 3 clinical and manufacturing operations. The role ensures compliance with GMP, GCP, and GLP requirements through direct oversight of key QA processes, including document control, training, supplier quality, deviations/CAPA, and batch disposition.

Duties And Responsibilities

• Establish and execute operational objectives and work plans for GxP quality systems aligned with organizational and program priorities
• Contribute to the development, implementation, and continuous improvement of QA policies, procedures, and standards affecting clinical and manufacturing operations
• Drive optimization and scalability of quality systems to support late-stage clinical development and commercial readiness
• Manage and continuously improve multiple QA functional areas, including document control, training systems, supplier quality, quality events (deviations, CAPA, change control, nonconformance), and batch disposition
• Ensure compliant and timely execution of core QMS processes, including investigation closure, documentation accuracy, and adherence to regulatory expectations
• Establish and monitor quality metrics, trends, and reporting to assess system effectiveness and identify risks
• Lead and coordinate inspection readiness activities, ensuring ongoing audit preparedness across quality systems and operations
• Oversee internal, external, and regulatory audit activities, including preparation, execution, and timely resolution of findings
• Ensure appropriate identification, escalation, and mitigation of quality and compliance risks with potential operational or regulatory impact
• Persist cross-functionally with Clinical Operations, Manufacturing, Regulatory Affairs, and R&D to align on quality requirements and operational execution
• Influence cross-functional decision-making related to quality, compliance, and risk management
• Communicate quality system performance, risks, and priorities to senior management and key stakeholders
• Delegate work, manage priorities, and ensure alignment of team deliverables with departmental and organizational goals
• Foster a culture of accountability, quality, and continuous improvement across the team and broader organization
• Lead or sponsor cross-functional initiatives to improve quality system effectiveness and operational performance
• Mentor junior staff and contribute to knowledge sharing across the organization

Education And Experience

• Bachelor’s degree in life sciences, health sciences, or related field (advanced degree preferred)
• Minimum 8 years of experience in the cGMP pharmaceutical or biotechnology industry; Latestage clinical to commercial manufacturing environments and/or Stem cell manufacturing experience is preferred
• Experience with electronic QMS and/or electronic batch record (EBR) systems is a plus
• Minimum 5 years of experience in conducting internal and external audits; Certified Quality Auditor (CQA) or equivalent preferred
• Minimum 5 years of direct people management or supervisory experience

Job Specifications

• Quality Systems Leadership: Ability to design, optimize, and scale core QMS processes to ensure compliance, efficiency, and long-term sustainability
• Regulatory Expertise: Advanced knowledge of GMP, GCP, GLP, and global regulatory frameworks (FDA, EMA, ICH) and their practical application
• Strategic Execution: Ability to translate functional strategies into operational plans, priorities, and measurable outcomes
• Risk Assessment: Strong capability to apply risk-based decision-making to identify, evaluate, and mitigate compliance and operational risks
• Cross-Functional Influence: Ability to align stakeholders, drive decisions, and influence outcomes across multiple functional areas
• People Leadership: Proven ability to build, develop, and lead high-performing teams through coaching, accountability, and performance management
• Inspection Readiness: Deep understanding of audit and inspection expectations with the ability to maintain continuous state of readiness
• Operational Excellence: Ability to evaluate processes, identify improvement opportunities, and implement scalable solutions
• Communication: Strong written and verbal communication skills with the ability to convey complex concepts to diverse audiences
• Analytical Thinking: Ability to interpret data, assess trends, and support decision-making through insights and problem-solving

WORKING CONDITIONS

• General Office Environment
• This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer
• The noise level in the work environment is usually quiet to moderate
• Some Cleanroom access is required

PHYSICAL DEMANDS

• While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear
• The employee must occasionally lift and/or move up to 15 pounds

Total Rewards And Culture

• Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type
• We are committed to creating an inclusive environment for all employees
• Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need
• The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks
• The anticipated salary range for candidates who will work in San Diego is $160k-$186k annually
• The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc
• Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states