Associate GCP/GLP QA Director
Exelixis
3 months ago
Remote friendly (Alameda, CA)
United States
$177,500 - $251,500 USD yearly
Operations
Responsibilities:
- Design and coordinate Quality system standards across Clinical Quality Assurance.
- Assess current state, identify gaps, develop action plans, implement improvements, and monitor GCP QA Quality Systems and internal processes.
- Develop, track, and manage periodic management reports with track-and-trend data for key Clinical/QA metrics.
- Review and approve Deviations and Corrective and Preventive Actions (CAPAs).
- Partner with Regulatory Affairs, Clinical Operations, and Translational Medicine to address compliance issues and provide compliance guidance.
- Maintain knowledge of Health Authority regulations/standards and inform Clinical Development stakeholders of potential organizational impact.
- Represent CQA in internal presentations on quality issues, initiatives, and projects.
- Identify issues and risks, propose options/solutions, and escalate risks in a timely manner.
- Participate in identifying and implementing process and system improvements.
Qualifications (Education/Experience):
- Bachelor’s degree in science + 11+ years relevant experience, OR
- Master’s degree in science + 9+ years relevant experience, OR
- PhD in science + 5+ years relevant experience, OR
- Equivalent combination of education and experience.
- 10+ years relevant experience in pharmaceutical/biotech industries.
- Experience in Good Clinical Practices (highly desired).
- Demonstrated experience with Quality Systems, including critical analysis and continuous improvement.
- Strong understanding of Quality Risk Management.
- Proficiency using standard MS Office.
Skills/Knowledge:
- Understanding of drug development and QA oversight of clinical trials.
- Experience developing business strategies, metrics, and continuous improvements.
- Working knowledge of Health Authority rules and regulations.
- Ability to manage Quality Systems (GCP completeness/acceptability).
- Ability to apply Quality Risk Management across Quality Systems.
- Ability to influence others, collaborate, and negotiate solutions.
- Excellent verbal and written communication; strong interpersonal skills.
- Detail-oriented; sound judgment within defined procedures.
Benefits:
- 401k with company contributions; medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (sales-based incentive for field sales); company stock purchase; long-term incentives; 15 vacation days (first year); 17 paid holidays (incl. winter shutdown in December); up to 10 sick days.
Working Conditions:
- Primarily labs/office; infrequent travel may be required.
- Design and coordinate Quality system standards across Clinical Quality Assurance.
- Assess current state, identify gaps, develop action plans, implement improvements, and monitor GCP QA Quality Systems and internal processes.
- Develop, track, and manage periodic management reports with track-and-trend data for key Clinical/QA metrics.
- Review and approve Deviations and Corrective and Preventive Actions (CAPAs).
- Partner with Regulatory Affairs, Clinical Operations, and Translational Medicine to address compliance issues and provide compliance guidance.
- Maintain knowledge of Health Authority regulations/standards and inform Clinical Development stakeholders of potential organizational impact.
- Represent CQA in internal presentations on quality issues, initiatives, and projects.
- Identify issues and risks, propose options/solutions, and escalate risks in a timely manner.
- Participate in identifying and implementing process and system improvements.
Qualifications (Education/Experience):
- Bachelor’s degree in science + 11+ years relevant experience, OR
- Master’s degree in science + 9+ years relevant experience, OR
- PhD in science + 5+ years relevant experience, OR
- Equivalent combination of education and experience.
- 10+ years relevant experience in pharmaceutical/biotech industries.
- Experience in Good Clinical Practices (highly desired).
- Demonstrated experience with Quality Systems, including critical analysis and continuous improvement.
- Strong understanding of Quality Risk Management.
- Proficiency using standard MS Office.
Skills/Knowledge:
- Understanding of drug development and QA oversight of clinical trials.
- Experience developing business strategies, metrics, and continuous improvements.
- Working knowledge of Health Authority rules and regulations.
- Ability to manage Quality Systems (GCP completeness/acceptability).
- Ability to apply Quality Risk Management across Quality Systems.
- Ability to influence others, collaborate, and negotiate solutions.
- Excellent verbal and written communication; strong interpersonal skills.
- Detail-oriented; sound judgment within defined procedures.
Benefits:
- 401k with company contributions; medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (sales-based incentive for field sales); company stock purchase; long-term incentives; 15 vacation days (first year); 17 paid holidays (incl. winter shutdown in December); up to 10 sick days.
Working Conditions:
- Primarily labs/office; infrequent travel may be required.