Sr. Director, Quality Assurance
Sr. Director, Quality Assurance
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 245000 - 273000
1 Vacancy
Job Description
Company:
At Annexon Biosciences we are a biopharmaceutical company advancing a latestage clinical platform of novel therapies for people living with devastating classical complementmediated 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 proofof concept data in GuillainBarr syndrome Huntingtons disease and geographic atrophy we are rigorously advancing our midto latestage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon youll 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.
Were seekingexceptional talent from all backgrounds to fuel our growth. At Annexon were building a diverse equitable and inclusive workplace. We value unique perspectives and unconventional paths. If youre the best candidate for the job even if you dont perfectly fit the traditional mold we encourage you to more about our commitment to diversity equity inclusion and our companyculture!
Position:
Senior Director Quality Assurance (QA) is responsible for ensuring that manufacturing and quality operations comply with all regulatory and internal standards leading QA/QC teams managing audits and inspections and driving continuous improvement across GMP processes.
Responsibilities include:
- Oversee all GMP activities to ensure compliance with regulatory requirements (FDA EMA ICH etc.) and the internal quality standards
- Maintain and organize GMP related documentation systems and programs records
- Manage and execute the GMP audit programs including conducting qualifications audits supporting investigations and ensuring inspection readiness
- Provide leadership and direction for Quality Assurance (QA) and Quality Control (QC) teams including hiring training and performance evaluations
- Approve batch disposition deviations change controls and corrective and preventive actions (CAPA)
- Lead cross functional teams to resolve complex quality and compliance issues drive continuous improvement and implement process optimization
- Maintain and improve Quality Management Systems (QMS) ensuring effective management of batch records audits investigations and compliance metrics
- Collaborate with internal and external partners including contract manufacturers (CDMO) to ensure manufacturing processes meet GMP standards and regulatory expectations
- Prepare and present updates on quality performance risks and issues to senior management
- Oversee regulatory inspections and responses and ensure training programs are in place for GMP compliance
Education Experience and Skills:
Required:
- B.S./M.S. in life science biotechnology or a related field
- Extensive experience 1015 in GMP quality assurance or manufacturing within the biotechnology or pharmaceutical industry standards (e.g. CFR GLP)
- Strong leadership communication and problemsolving skills with a proven ability to manage teams and complex projects
- Able to work effectively with cross functional teams
- Veeva experience a plus
Salary Range:$245000 to $273000
Location:Annexon Biosciences is located in Brisbane California and preference is given to candidates in the San Francisco Bay Area. This position may be onsite or remote (within the US).
Benefits:
- A stimulating and rewarding workplace includes flexible work schedules remote opportunities and the ability to achieve a worklife balance.
- Shuttle service from BART CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation employee stock purchase plan as well as a comprehensive health benefit package that includes medical dental vision 401(k) flexible spending plans and other 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.
Required Experience:
Director
Employment Type
Full Time
