Director, Quality Systems – Validation

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Neumora

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2021

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Neumora is redefining the field of neuroscience drug development by pioneering a new era of precision medicines for brain diseases. With a focus on developing targeted and effective therapies, Neumora aims to address the global brain disease crisis that affects over 1. 5 billion people. Their innovative approach revolves around the development of therapeutically relevant targets in Central Nervous System (CNS) diseases, emphasizing novel mechanisms of action and best-in-class pharmacology. The company's efforts are supported by their Precision Toolbox, which integrates translational, clinical, and computational tools to advance precision medicine approaches. Neumora is committed to transforming the future treatment of brain diseases by assembling a team of dedicated neuroscience drug developers and data scientists.

📋 Description

• Oversees the management and development of QMS programs: deviations, events, CAPAs, change control, vendor/supplier lifecycle management; audit – vendor, clinical investigator site, self-inspection/audit; quality technical agreement; risk management. • Oversees, maintains, and manages the process of qualifying, re-evaluating, determining risk score and status to vendors. Works with quality counterparts to ensure appropriate responses are provided and CAPA closured as part of the audit process. • Creates, maintains, and manages master audit schedules. • Manages and/or performs compliance audits according to established audit schedule or project objectives. • Manages the creation/revision of quality technical agreements. • Establishes, maintains, and manages key quality indicator (KQI) metrics program for the areas of responsibility. • Oversees the internal audit program and ensures associated CAPA are closed according to established timelines. • Performs, strategizes, and executes QMS reviews and gap analyses plus their resolution plans to ensure phase appropriate compliance and consistent QMS approaches. • Supports regulatory submissions data integrity and compliance reviews and the review of ongoing updates to regulatory filings against source documentation. Ensures gaps identified are adequately remediated before submission. • Leads the remediation of gaps identified in all areas of responsibility to assure cGMP compliance and inspection readiness. • Supports the QMS compliance infrastructure, as needed, including, but not limited to, document control, training program, and quality event programs (e.g., Deviation, CAPA, Investigation, Change Control). • Supports the facilitation of regulatory authority inspections. • Collaborates within and across departments to ensure achievement of company goals, including compliance with all applicable standards and provide quality and compliance guidance. • Creates and leads QA initiatives that drive quality management systems to a state of operational excellence.

🎯 Requirements

• Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy, or other related scientific discipline with a minimum of 10 years’ experience in QA Compliance • Other Compliance or Regulatory certifications (e.g. RAC, ASQ) a plus • Experience working with a sponsor company from Phase I through commercial QMS • Experience auditing suppliers, CRO, CMOs, CTLs, and clinical sites • Experience with electronic QMS platforms (ex.Veeva) • Practical knowledge of GxP and an ability to apply sound judgment and decision-making skills (risk based and appropriate for the phase of clinical development) to support product release • Working knowledge of US and EU GxP regulations and guidelines required • Working knowledge of other world GxP regulations and guidelines beneficial • Strong organization and time management skills required with minimal oversight • Strong leadership and influencing skills a must • Willingness to travel approximately 5 to 15% (varies based on activities per month)

🏖️ Benefits

• Medical, dental, vision, and life insurance • 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution) • Company Equity (New Hire Awards, Annual Awards, ESPP) • Annual paid time off: • Accrued Vacation Days: 15 days per year • Sick Days: 10 days per year • Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December • Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability • Discretionary year-end bonus