Director, Quality Engineering

🕒 February 18

🏄 California – Remote

🏄 California – Remote

💵 $190k - $223k / year

⏰ Full Time

🔴 Lead

🔧 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 development and execution of global GMP quality engineering strategies aligned with regulatory expectations and business objectives. • Serve as the organizational lead for Quality Risk Management (QRM), establishing risk-based approaches to identify, evaluate, and mitigate quality and compliance risks. • Drive continuous improvement (CI) initiatives using tools such as Lean, Six Sigma and root cause analysis to improve product quality, process robustness, and operational efficiency. • Oversee the enhancement and maintenance of core quality systems (e.g., CAPA, deviation management, change control, batch release, investigations) to ensure effectiveness and inspection readiness. • Strengthen data integrity controls and drive global initiatives to ensure compliance with ALCOA+ principles. • Lead quality oversight for manufacturing activities, tech transfer, scale-up, validation, and commercial production to ensure end-to-end GMP compliance. • Provide strategic direction during regulatory inspections (FDA, EMA, MHRA, PMDA) and internal audits; ensure timely resolution of observations and sustainable remediation. • Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, Supply Chain, and Commercial teams to embed quality into operational decision-making and strategic planning. • Develop and implement risk-based monitoring and metrics to proactively assess performance and compliance trends. • Guide quality input for new product introductions (NPI), clinical and commercial launches, and global supply chain strategies to ensure product availability and regulatory alignment. • Lead and mentor a global team of quality engineers and specialists; build capabilities through training, coaching, and talent development. • Represent the Quality function in strategic business forums and quality governance meetings; act as a key quality liaison to executive leadership and health authorities. • Foster a culture of quality excellence, ownership, and continuous learning throughout the organization.

🎯 Requirements

• Bachelor’s degree in a science discipline and at least 12 years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) with a minimum of 8 years supervisory/leadership experience • Deep technical expertise in GMP-compliant manufacturing environments • Thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA) • Experience leading quality transformation initiatives that deliver both regulatory confidence and operational excellence • Candidate must have strong background in Drug Substance and/or Drug Product Manufacturing, experience with small molecules and solid oral dose development is a plus • Strong organizational and interpersonal skills, with a keen attention to detail • Must be able to communicate efficiently with Contract Manufacturing Organizations and with internal cross-functional teams • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment • Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner • Must possess excellent communication skills, both verbal and written. and ability to write concise SOP’s • Strong self-motivation as well as the ability to work independently, and in a team environment with minimum supervision • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form • Ability to identify situations that will require management intervention for resolution

🏖️ Benefits

• discretionary annual target bonus • stock options • 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