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. This is a hybrid "player-coach" position that combines hands-on individual contributor responsibilities with leadership of junior quality team members, including performance management, strategy, and administrative oversight

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
• Partner 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
• Travel: Ability and willingness to travel nationally to support GxP audit readiness

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.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job

Total Rewards and Culture:

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.