Associate Director Quality Assurance - San Diego, United States - Elixir Associates
Description
Company:
Elixir Associates is currently partnering with an exciting Clinical-stage, Cell Therapy Biotech based in Southern California. The company is looking for an Associate Director, Quality Assurance (GCP).
About The Job:
Reporting to the Head Of Quality Assurance, the Associate Director, Quality Assurance (GCP) will play a crucial part in ensuring the successful achievement of clinical program objectives by ensuring compliance with all relevant regulations, including local, state, FDA, and other applicable agencies.
Your responsibilities will encompass overseeing all aspects of Clinical Quality, managing external Contract Research Organizations (CROs), and providing additional support for internal quality systems.
Additionally, you will spearhead GCP compliance strategies and play a key role in all clinical program teamsKey Responsibilities:
Supervise:
Ensure quality standards across internal processes, CROs, vendors, and investigator sites.
Aid:
Contribute to developing documentation and implementing systems and SOPs.
Evaluate:
Review internal and external records to ensure compliance with regulations and procedures.
Adhere:
Follow FDA, ISO, ICH, and company policies and procedures.
Assist:
Support all identified needs of the Quality department as directed by management.
Stay Informed:
Keep up-to-date with new regulations, guidelines, inspection reports, and relevant literature.
Required Experienced:
Bachelors or Masters degree in a scientific discipline.
At least 8 years of related experience with a Masters degree (or 10 years with a Bachelors degree), including a minimum of 5 years in Clinical Quality Management within the pharmaceutical or biotech industry.
Experience and expertise in establishing and managing quality systems, conducting vendor and investigator site audits, and overseeing CROs.Proficient knowledge of FDA and ICH regulatory guidance and regulations.
Equivalent combination of education and experience will be considered.
Strong organizational skills.
Highly skilled in MS Office 365, particularly MS Word.
Salary & Compensation:
Base Salary
Targeted Yearly Bonus
Stock
Healthcare Benefits
If this opportunity is of interest or you would like to find out more, please reach out to any of our team members over LinkedIn.
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