Director, Clinical QA – Global Compliance Leader

BioSpace; South San Francisco (CA); On-site; USD 190,000 - 240,000; Full time

Benefits offered by this job

Health insurance premiums covered at 90%

Free access to transportation programs

$100 monthly cell phone stipend

Unlimited PTO for exempt employees

Free onsite gym and stocked kitchen

Job summary

A leading life sciences company in South San Francisco is seeking a Director of Clinical Quality Assurance to ensure compliance with FDA regulations and oversee GCP QA programs. The ideal candidate will have extensive experience in clinical quality assurance and expertise in small molecule products. This position offers competitive compensation and a range of benefits, including stock options and health insurance.

Qualifications

• Minimum 10 years of Clinical Quality Assurance experience.
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.
• Ability to make timely decisions in complex situations.

Responsibilities

• Establish, maintain and enhance GCP QA programs and policies.
• Ensure clinical programs comply with health authority regulations.
• Provide quality oversight of key clinical and IND/NDA enabling documents.

Skills

Good Clinical Practices

FDA regulations

Risk management

Quality Management Systems

Communication skills

Education

Bachelors or advanced degree in Biology, Chemistry, or related field

Job description

A leading life sciences company in South San Francisco is seeking a Director of Clinical Quality Assurance to ensure compliance with FDA regulations and oversee GCP QA programs. The ideal candidate will have extensive experience in clinical quality assurance and expertise in small molecule products. This position offers competitive compensation and a range of benefits, including stock options and health insurance.