What are the responsibilities and job description for the Director/Senior Director, Clinical Quality Assurance position at Annexon Biosciences?
Company :
At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington's disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you'll be part of a team committed to making an impact together.
For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.
We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!
Position :
Annexon Biosciences seeks a Director / Senior Director, Quality Assurance (QA) to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Annexon's functional areas. The candidate will perform audits of service providers, study sites, and internal processes. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP focused team setting and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Annexon's clinical stakeholders and act as a catalyst for continuous process improvement.
Responsibilities include :
- Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of the Annexon product pipeline.
- Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI).
- Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA and EU regulations / directives / requirements and ICH guidelines
- Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
- Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
- Build training curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
- Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities. Prepare regular reports and presentations for senior / executive management highlighting quality performance, trends, and areas for improvement.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers.
- Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards, and guidelines.
- Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
- Lead and / or manage additional Clinical Quality Assurance (GCP) initiatives or programs as needed.
Education, Experience, and Skills :
Salary Range : Director ($199,000 - $222,0000) / Sr. Director ($244,000 - $272,000)
Location : Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.
Benefits :
Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.
Staffing Agencies : Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs / resumes through Annexon's website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.com.
Salary : $199,000 - $2,220,000