Director, Quality Assurance – GCP

Job not on LinkedIn

2 days ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $180k - $225k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Crinetics Pharmaceuticals

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Oversee the development, implementation, maintenance, and performance of GCP Quality Assurance systems • Ensure clinical trials and research activities adhere to regulatory requirements and internal policies • Develop and implement risk management strategies to identify, assess, and mitigate risks • Drive initiatives that foster a culture of quality and continuous improvement • Lead investigations of significant complexity and present to executive management • Manage and mentor quality assurance team members • Represent QA at program-wide meetings and provide GCP guidance • Manage quality events, CAPAs, and deviations • Ensure adequate systems and controls are in place for GCP compliance • Execute GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends

🎯 Requirements

• Minimum Bachelor’s degree in a science discipline • At least 12 years’ experience in a QA function within the pharmaceutical/biotech industry • Minimum of 8 years of working in a GCP QA function • Previous experience leading inspection readiness and audits • Thorough understanding of FDA, EU and local regulations • Understanding of ICH guidelines • Hands-on experience in developing and implementing GCP procedures • Strong working knowledge of GCP and GLP regulations • Proven ability to cultivate and develop relationships with cross-functional teams and vendors • Demonstrated leadership ability to identify, manage and develop QA teams • Must be able to make critical and strategic decisions based on risk-assessments • Capable of managing multiple projects simultaneously • Excellent communication and listening skills. • Auditing certification is a plus

🏖️ Benefits

• Discretionary annual target bonus • Stock options • Employee Stock Purchase Plan (ESPP) • 401k match • Top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown