Senior Manager, Clinical Quality Assurance

🕒 September 4

🇺🇸 United States – Remote

💵 $140k - $180k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 13%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Elevar Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $20M Venture Round - Elevar Therapeutics on 2018-07

Biotechnology • Pharmaceuticals • Healthcare

Elevar Therapeutics is a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. With a foundation rooted in oncology, the company is dedicated to identifying and developing promising medicines for complex and under-treated health conditions across a range of therapeutic areas. Elevar Therapeutics takes a relentless and inventive approach towards advancing next-generation therapies that aim to set new standards of care and improve patient experiences, all while maintaining the highest ethical standards.

📋 Description

• Support Quality oversight of clinical activities • Perform and manage clinical quality assurance activities • Ensure clinical trials meet the highest GCP and quality standards • Ensure clinical processes follow corporate SOPs, guidelines, and regulations • Ensure processes contributing to clinical trial performance are conducted properly • Prepare and manage the Drug Development Quality Management Plan, including risk management, SOPs, training, regulatory compliance, and audit readiness • Evaluate the adequacy of quality assurance standards for the Drug Development Group • Interface with Drug Development departments and corporate QA regarding vendor, site, and internal GCP audits • Evaluate audit findings and review/approve corrective actions • Support preparation of materials for regulatory agency submissions • Evaluate quality events, incidents, and queries • Provide clinical operations expertise in cross-functional meetings • Work directly or manage teams working on compliance and quality according to Elevar SOPs, ICH guidelines, and GCP best practices • Draft clinical quality assurance policies and procedures • Ensure inspection readiness of regulated activities

🎯 Requirements

• Bachelor’s degree with 12 years' experience; or Master’s degree with 5 years' experience • Proven management experience demonstrating business acumen • Experience developing and delivering functional/department goals • Experience delivering results and championing innovation • Experience managing remote and cross-functional teams • More than 5 years of Clinical Quality-related experience in the biotech/pharmaceutical industry • Experience with Clinical Quality requirements in Europe • Experience in oncology therapeutic area • Expert knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines • Knowledge of FDA CFR, PhRMA code, clinical research ethics, HIPAA and patient privacy laws, EU Directive, and other applicable international regulations • Thorough working knowledge of compliance and inspection readiness • Strong computer skills, including Microsoft Office, QA applications, and databases • Knowledge of QA tools, concepts, and methodologies • Record of successfully completed FDA and regulatory authority inspections • Data collection, management, and analysis • Problem analysis and problem-solving • Ability to demonstrate Elevar’s core values while collaborating effectively and working remotely

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Time off • Retirement plan • Other voluntary benefits • Competitive wages