Sr. Manager, QA

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 EEO and Employment Eligibility: 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 is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future. 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. Apply for this job First name Last name Email address Location Phone number Resume Attach resume Attach another file Attach file Add another What are your salary

requirements? Are you authorized to work in the United States? Yes No Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Yes No Linkedin url Should be {http://www.linkedin.com/pub/[member-name/]x/y/z} or {http://www.linkedin.com/in/string} © 2014-2026 TriNet Group, Inc. All rights reserved. Privacy Policy

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