Senior Manager, Clinical Quality Assurance
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Job Description
Senior Manager overseeing clinical quality assurance for Elevar Therapeutics’ biotech clinical trials. Ensuring GCP compliance, audit readiness, regulatory submissions, and inspection preparedness.
Responsibilities:
- 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
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