Director, Quality Engineering

Director, Quality Engineering page is loaded## Director, Quality Engineering remote type:
Remote time type:
Full time posted on:
Posted 3 Days Agojob requisition :
JR000561

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline.

We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
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* POSITION SUMMARY:

** The Director of Quality Engineering will lead the development, integration, and execution of strategic GMP quality initiatives within a fast-paced, highly regulated pharmaceutical environment. This key leadership role is responsible for embedding a proactive, risk-based mindset across global operations to ensure product quality, patient safety, and sustained regulatory compliance.

As the enterprise lead for Quality Risk Management (QRM) and Continuous Improvement (CI), the Director will oversee the design and implementation of scalable, risk-based quality frameworks that anticipate and mitigate compliance and supply chain risks. Responsibilities include strengthening inspection readiness, reinforcing data integrity, and driving a robust Corrective and Preventive Action (CAPA) culture across the organization. The role will also lead initiatives to optimize quality systems and deliver measurable performance improvements across the value chain.

Working cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, Commercial, and Supply Chain teams, the Director will ensure GMP compliance throughout the product lifecycle - from technology transfer and scale-up to commercial manufacturing and distribution. A strong emphasis will be placed on global GMP alignment, system effectiveness (e.g., change control, deviation management, batch disposition), and cultivating a culture of accountability, transparency, and continuous learning.

The ideal candidate will have deep technical expertise in GMP-compliant manufacturing environments, a thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA), and a proven track record of leading quality transformation initiatives that deliver both regulatory confidence and operational excellence. This is a high-impact role offering the opportunity to shape the company’s global quality strategy and build a culture of quality excellence - ultimately improving operational performance and advancing patient outcomes worldwide.
** ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
** These may include but are not limited to:
* 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…