Senior Manager, Clinical Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide oversight for the quality of clinical activities.

• Conduct and oversee clinical quality assurance tasks.

• Ensure that clinical trials adhere to the highest standards of GCP and quality.

• Verify that clinical processes align with corporate SOPs, guidelines, and regulations.

• Ensure that processes essential to clinical trial performance are executed correctly.

• Develop and oversee the Drug Development Quality Management Plan, which includes risk management, SOPs, training, regulatory compliance, and audit preparedness.

• Assess the adequacy of quality assurance standards within the Drug Development Group.

• Collaborate with Drug Development departments and corporate QA concerning vendor, site, and internal GCP audits.

• Review audit findings and approve corrective actions.

• Assist in preparing materials for submissions to regulatory agencies.

• Analyze quality events, incidents, and inquiries.

• Offer clinical operations expertise during cross-functional meetings.

• Directly work with or manage teams focused on compliance and quality in accordance with Elevar's SOPs, ICH guidelines, and GCP best practices.

• Create clinical quality assurance policies and procedures.

• Guarantee readiness for inspections of regulated activities.

⛳️ Requirements

• Bachelor’s degree with 12 years of experience or a Master’s degree with 5 years of experience.

• Demonstrated management experience showcasing business acumen.

• Proven track record in developing and achieving functional/department goals.

• Experience in delivering results and driving innovation.

• Ability to manage remote and cross-functional teams effectively.

• Over 5 years of experience in Clinical Quality within the biotech/pharmaceutical sector.

• Familiarity with Clinical Quality requirements in Europe.

• Experience in the oncology therapeutic area.

• In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Understanding of FDA CFR, PhRMA code, clinical research ethics, HIPAA, patient privacy laws, EU Directive, and other relevant international regulations.

• Comprehensive knowledge of compliance and inspection readiness.

• Proficient in computer skills, including Microsoft Office, QA applications, and databases.

• Familiarity with QA tools, concepts, and methodologies.

• Proven history of successfully passing FDA and regulatory authority inspections.

• Experience in data collection, management, and analysis.

• Strong problem analysis and problem-solving capabilities.

• Ability to embody 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