Senior Manager, GMP Vendor Quality

April 4

🏄 California – Remote

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

💵 $139k - $173k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Crinetics Pharmaceuticals

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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.

Drug Discovery • Endocrinology • RareDisease • Biotech

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Responsible for oversight of GMP Vendor performance • Overseeing the GMP Vendor Assurance program • Ensure compliance with Crinetics policies, FDA, European, and other regulations • Develop partnerships internally and externally with contract organizations and strategic partners • Support GMP outsourced operations for small molecule therapeutics

🎯 Requirements

• Bachelor’s degree with a scientific or technical discipline • 8 years of relevant experience in a regulated, GMP environment • 5 years of leadership, continuous improvement, and/or project management experience • Demonstrated knowledge of FDA/EMA/ICH standards and regulations • Experience working with Contract Management Organizations and/or auditing CMOs • Knowledge of Quality Systems, Manufacturing, and Analytical Control Strategies • Experience with product complaints, stock recovery, recall, and field alert processes • Ability to effectively organize, prioritize, and work in a fast-paced environment • Strong project management skills with the ability to manage multiple projects and execute in adherence to timelines

🏖️ Benefits

• Discretionary annual target bonus • Stock options • ESPP • 401(k) match • Health insurance plans for employees and families including medical, dental, vision, and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown