The Associate Director, Quality Assurance strategic and operational leadership for the ongoing improvement of GxP quality systems and teams supporting late-stage clinical development, manufacturing, and commercial readiness. The role shapes and executes quality system strategy, establishes risk-based governance, and ensures that GMP, GCP, and GLP requirements are integrated across clinical and manufacturing operations. The Associate Director leads multiple QA functional areas, including document control, training, supplier quality, quality events, audit and inspection readiness, and batch disposition; advises senior leaders on significant quality and compliance matters; and develops teams and scalable systems that support organizational objectives. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.
DUTIES AND RESPONSIBILITIES: - Partner with senior Quality leadership to establish and execute the strategy, objectives, operating model, and multi-year roadmap for GxP quality systems supporting clinical development, manufacturing, and commercial readiness.
- Translate organizational priorities into functional plans, governance, resource requirements, budgets, schedules, and measurable outcomes for assigned QA areas.
- Shape departmental policies, standards, and risk-based quality practices, and influence organizational decisions that affect product quality, patient safety, data integrity, and regulatory compliance.
- Direct and continuously improve multiple QA functions, including document control, training systems, supplier quality, quality events (deviations, CAPA, change control, non-conformance), and batch disposition.
- Ensure compliant and timely execution of core QMS processes and provide QA direction on complex investigations, quality events, supplier issues, and disposition matters.
- Establish metrics, dashboards, and management-review processes to assess quality system health, identify systemic trends, and drive timely risk-based decisions and remediation.
- Lead enterprise inspection readiness and oversee internal, external, partner, and regulatory audits, including response strategy, commitments, and sustainable remediation.
- Anticipate, assess, communicate, and mitigate significant quality and compliance risks; develop practical contingency plans and escalate matters of organizational significance with clear recommendations.
- Serve as a senior Quality partner across functions and governance forums, aligning stakeholders and communicating performance, risks, resource needs, and strategic recommendations to senior leadership.
- Oversee external partners and suppliers, lead cross-functional quality initiatives, and develop QA talent through clear accountability, coaching, succession planning, and a culture of continuous improvement.
EDUCATION AND EXPERIENCE: - Bachelor's degree in life sciences, health sciences, engineering, or a related field required; advanced degree preferred.
- Minimum 8 years of substantial experience in the cGMP pharmaceutical or biotechnology industry and progressive leadership of GxP quality systems in clinical and manufacturing environments.
- Late-stage clinical development, commercial manufacturing readiness, biologics, cell therapy, or stem cell manufacturing experience strongly preferred.
- Minimum 7 years of experience leading internal, external, supplier, or regulatory audits and inspection-readiness activities; Certified Quality Auditor (CQA) or equivalent certification preferred.
- Minimum 7 years of progressive people leadership experience, including responsibility for developing teams, managing performance, allocating resources, and leading through organizational change.
- Experience with electronic quality management systems and electronic batch record systems preferred.
JOB SPECIFICATIONS: - Quality Systems Leadership: Advanced capability to design, optimize, and scale GxP quality systems for late-stage development, manufacturing, and commercial readiness to ensure compliance, efficiency, and long-term sustainability
- Regulatory Expertise: Advanced knowledge of GMP, GCP, GLP, and global regulatory frameworks including FDA, EMA, and ICH expectations, with the judgment to apply requirements to complex quality and operational decisions.
- Quality Strategy and Governance: Ability to translate company and functional objectives into an integrated quality strategy, governance model, priorities, policies, and measurable outcomes.
- Risk Assessment: Ability to evaluate ambiguous, high-impact issues, understand cross-functional interdependencies, and make timely, risk-based decisions that protect patients, product quality, compliance, and business continuity.
- Executive Influence: Ability to communicate with and influence senior and executive leaders on matters of organizational significance, including competing priorities, resource decisions, compliance risk, and remediation strategy.
- Cross-Functional Leadership: Ability to create alignment across functions, programs, partners, and external stakeholders and lead complex initiatives without relying solely on formal authority.
- Business Acumen: Strong understanding of the product development lifecycle, manufacturing operations, company priorities, and the biotechnology landscape to inform quality strategy and resource allocation.
- People Leadership: Proven ability to lead multiple workstreams or quality disciplines, develop leaders and technical talent, establish accountability, and build a high-performing quality culture.
- Inspection Readiness: Deep understanding of global audit and inspection expectations, with the ability to establish and sustain an organization-wide state of readiness and lead effective responses and remediation.
- Operational Excellence: Ability to establish plans, budgets, staffing models, schedules, performance measures, and external support strategies that meet corporate requirements.
- Communication: Exceptional written, verbal, and presentation skills with the ability to distill complex quality, technical, and regulatory matters into clear recommendations for diverse audiences.
- Analytical Thinking: Ability to synthesize metrics, trends, inspection intelligence, and operational data to identify systemic risk, evaluate effectiveness, and guide strategic decisions.
- Travel: Ability and willingness to travel nationally to support GxP audits, inspections, partner oversight, and quality activities.
WORKING CONDITIONSGeneral 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 DEMANDSWhile 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 $187,099 - $228,676 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.
