Executive Director Quality Systems & Compliance
Company: Aspen Neuroscience, Inc.
Location: San Diego
Posted on: November 22, 2021
Aspen is looking for strong leadership and quality expertise in
this new role reporting to the Senior Vice President Regulatory.
The Executive Director, Quality Systems and Compliance, will lead
all aspects of the company's quality organization including Quality
Systems and Compliance, Quality Engineering, Quality Control,
Quality Operations and GCP. This is a unique opportunity to build a
team in a culture where employees are respected and rewarded for
hard work, innovation, personal initiative, and collaboration.
- Represents all Quality functions on the Technical Operations
- Ensures GMP compliance while building teams and developing
people to create a culture of quality excellence.
- Directs and oversees Quality Systems and Compliance including
technical training, document control, compliance, inspection
readiness, quality systems, quality management reviews, supplier
quality and internal/external audits.
- Collaborates closely with F&E (Facilities and Equipment),
IT and manufacturing, to build and maintain a robust Quality
Engineering organization responsible for CQV (commissioning,
qualification, and validation), risk assessments, data integrity
and computer system validation.
- Accountable for all aspects of Quality Control including
analytical, specifications, sample management, stability, LIMS, raw
material testing and support technical regulatory submissions.
- Responsible for the strategic development and deployment of
Aspen's quality operating model including quality sub-functions and
- Build and deploy a team that delivers material testing,
environmental monitoring, methods and supports facility
qualification and validation.
- Working closely with manufacturing and process development,
leads a Quality Operations group that supports deviation
resolution, CAPA, MBR review.
- Oversees a team who are responsible for clinical sites / CRO
- Drives continuous improvement through effective organizational
management, budgeting, reporting, project management and
operational excellence within the function. Education and
- Degree in the biological sciences; PhD or MS preferred.
- 15+ years of technical experience in GMP pharmaceutical or
biologics manufacturing environment. Cell Therapy experience is
- Experience in both QC and QA is preferred.
- 10+ years of experience in a leadership Quality management role
- Exceptional understanding of fundamental quality concepts
including aseptic manufacturing, process validation and control and
- Demonstrated ability to successfully interact with health
authorities at regulatory meetings and inspections.
- Demonstrated ability to act as change agent and make objective,
inclusive, robust an unbiased decision with imperfect
- 8 years of experience in the pharmaceutical or biotechnology
industry and 4 years of experience in conducting internal and
- Experience managing the QA & QC function
- Certified Quality Auditor (CQA) certification preferred
- Knowledge of regulations and standards affecting
Pharmaceuticals, and Biologics.
- Knowledge and application of GMP/GCP/ICH standards and
regulatory guidance documents
- Strong capabilities in auditing and writing formal audit
- Strong understanding of cGMP, GLP, GCP and GvP compliance
requirements associated with US, EU, ICH and other pertinent
- Strong listening skills and exceptional written and verbal
- Visionary thinker with a desire to excel and inspire
- Self-reliant, passionate, enthusiastic with a focus on driving
- Structured and well organized
- Able to travel 25% of the time
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, gym membership, and
other wellness perks.
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. To apply: Please email your resume to
Keywords: Aspen Neuroscience, Inc., San Diego , Executive Director Quality Systems & Compliance, Executive , San Diego, California
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