Senior Manager, Quality Engineering

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $133k - $166k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

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.

📋 Description

• Lead the administration and day-to-day execution of the GMP Quality Risk Management (QRM) program across GMP quality, development and commercial operations. • Facilitate structured risk assessments (e.g., FMEA, risk ranking/filtering) with cross-functional SMEs to ensure consistent identification, categorization, and quantification of risk. • Partner with Technical Operations project teams to embed risk-based decision making into: Product development lifecycle, Technology transfer, Process validation and continued process verification, Manufacturing and supply chain activities. • Ensure risks are appropriately documented, trended, escalated, and maintained through their full lifecycle within QMS tools. • Establish and maintain risk registers, dashboards, and metrics to provide visibility into risk profiles and trends. • Drive alignment between QRM outputs and core quality systems (e.g., deviations, CAPA, change control). • Serve as the Quality Engineering representative on project teams or facilitate structured touchpoints with project leads to ensure integration of QRM principles.

🎯 Requirements

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Engineering or related field) • Minimum of 12 years of experience in Quality Assurance within pharmaceutical/biotech GMP environments • Demonstrated experience in Quality Risk Management methodologies (e.g., ICH Q9, FMEA, risk ranking) • Strong knowledge of GMP regulations and global expectations (e.g., FDA, EMA) • Experience supporting manufacturing, tech transfer, validation, and/or commercial operations • Proven ability to facilitate cross-functional risk assessments and drive outcomes • Strong communication, organizational, and influencing skills • Ability to manage multiple priorities in a fast-paced environment

🏖️ Benefits

• Health insurance plans for employees (and their families) • Discretionary annual target bonus • Stock options • ESPP • 401k match • 20 days of PTO • 10 paid holidays • Winter company shutdown