Associate Director, Quality Assurance

Aspen Neuroscience•San Diego, CA

9h•$187,099 - $228,676•Onsite

About The Position

The Associate Director, Quality Assurance provides 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 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. The role advises senior leaders on significant quality and compliance matters and develops teams and scalable systems that support organizational objectives. This is an on-site position in Torrey Pines, California, with flexibility and availability for weekend and holiday work as needed. Relocation is not available. The position requires extensive experience in cGMP pharmaceutical or biotechnology environments, progressive leadership of GxP quality systems, audit and inspection-readiness expertise, and people leadership. National travel is required to support audits, inspections, partner oversight, and other quality activities.

Requirements

Bachelor's degree in life sciences, health sciences, engineering, or a related field.
At least 8 years of substantial experience in the cGMP pharmaceutical or biotechnology industry and progressive leadership of GxP quality systems in clinical and manufacturing environments.
At least 7 years of experience leading internal, external, supplier, or regulatory audits and inspection-readiness activities.
At least 7 years of progressive people leadership experience, including developing teams, managing performance, allocating resources, and leading organizational change.
Advanced knowledge of GMP, GCP, GLP, and global regulatory frameworks, including FDA, EMA, and ICH expectations.
Advanced capability to design, optimize, and scale GxP quality systems for late-stage development, manufacturing, and commercial readiness.
Ability to translate organizational objectives into quality strategy, governance, priorities, policies, and measurable outcomes.
Ability to evaluate ambiguous, high-impact issues and make timely, risk-based decisions that protect patients, product quality, compliance, and business continuity.
Ability to communicate with and influence senior and executive leaders on organizationally significant quality matters.
Ability to align functions, programs, partners, and external stakeholders and lead complex initiatives.
Strong understanding of the product development lifecycle, manufacturing operations, company priorities, and the biotechnology landscape.
Proven ability to lead multiple workstreams or quality disciplines, develop leaders and technical talent, establish accountability, and build a high-performing quality culture.
Deep understanding of global audit and inspection expectations and ability to establish organization-wide inspection readiness and lead responses and remediation.
Ability to establish plans, budgets, staffing models, schedules, performance measures, and external support strategies.
Exceptional written, verbal, and presentation skills to communicate complex quality, technical, and regulatory matters clearly.
Ability to synthesize metrics, trends, inspection intelligence, and operational data to identify systemic risk and guide strategic decisions.
Ability and willingness to travel nationally.
Ability to work on-site in Torrey Pines and be available for weekend and holiday work as needed.
Ability to work in a general office environment, use a computer, and access cleanrooms as required.
Regularly stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms, and talk or hear; occasionally lift and/or move up to 15 pounds.
Specific vision abilities include close, distance, color, and peripheral vision, depth perception, and ability to adjust focus.
Must have valid work authorization that does not require employer sponsorship now or in the future; visa sponsorship is unavailable.

Nice To Haves

Advanced degree.
Late-stage clinical development, commercial manufacturing readiness, biologics, cell therapy, or stem cell manufacturing experience.
Certified Quality Auditor (CQA) or equivalent certification.
Experience with electronic quality management systems and electronic batch record systems.

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 decisions affecting 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, 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 contingency plans and escalate organizationally significant matters 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 accountability, coaching, succession planning, and continuous improvement.
Travel nationally to support GxP audits, inspections, partner oversight, and quality activities.