Senior Director Quality (remote)
Senior Director Quality (remote)
Elevation Oncology
United States
See who Elevation Oncology has hired for this role
Senior Director, Quality
The Senior Director of Quality will lead our quality team and play a critical role in ensuring that our drug development activities meet regulatory requirements and adhere to the highest quality standards. This position offers the opportunity to establish a Quality function and advise our leadership team on all aspects of Quality, from strategy to implementation. This position will work with other organizational teams to provide quality oversight and GXP (GCP/GLP/GMP) expertise throughout the product lifecycle, from preclinical and clinical development through commercialization.
Job Responsibilities:
- Develop phase-appropriate quality operating models in accordance with risk-based compliance guidance.
- Provide quality oversight for GXP (GCP/GLP/GMP) and pharmacovigilance activities and ensure organizational compliance.
- Partner with Regulatory Sciences to ensure compliance on regulatory submissions to FDA and other health authorities.
- Plan and conduct/coordinate GXP (GCP/GLP/GMP) audits, to ensure inspection readiness both internally and at vendors, in accordance with established timelines.
- Continue to build and expand the company’s quality systems to ensure that they are optimally designed and managed.
- Oversee major/critical deviation investigations to ensure minimal risk to product quality, efficacy, and safety.
- Manage the development and reporting of quality metrics, and periodic reporting describing compliance trends and any areas of risk with associated mitigation plans, including the annual quality review with the leadership team.
- Lead and facilitate quality-related continuous improvement initiatives and activities, performing gap analysis and risk communication.
- Ensure all quality agreements are effectively negotiated to meet the near- and long-term needs of the company in a cost-efficient manner.
- Oversee generating performance metrics and trends, including site metrics for investigation/CAPA, etc.
- Act as a trusted advisor to the leadership team by providing compliance guidance through collaborative review.
- Drive the quality culture throughout the organization.
Required Skills & Qualifications:
- Bachelor’s degree in a scientific discipline. Advanced degree (MS, PharmD, MD or PhD) preferred.
- 15+ years of experience of quality assurance and regulatory compliance experience in the biotech or pharmaceutical industry, including experience in oncology drug development.
- Demonstrated track record of managing quality systems to enable successful regulatory filings and drug or biologics approvals.
- Quality leadership and team management experience.
- Experience performing audits of critical suppliers and CMOs.
- Expert knowledge of U.S. GCP/GLP/GMP and pharmacovigilance regulations and quality guidelines, including industry best practices and standards in regulatory affairs and quality assurance. Knowledge of relevant Asia Pacific regulations and guidelines highly desired.
- Experience serving as a sponsor representative during a regulatory authority audit and communicating directly with an inspector.
- Substantial experience with CMC, clinical, and preclinical development, and regulatory submissions.
- In-depth understanding of the drug development, product commercialization, and life cycle management processes.
- Demonstrated proficiency in departmental budgeting, organizing, and planning.
- Demonstrated leadership competencies and strategic business perspective.
- Ability to thrive in a fully virtual/remote work environment with some business travel (up to 20%).
- Must be located in and authorized to work in the United States today and in the future.
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.
Search Firms and Agency Representatives: Elevation Oncology is not accepting unsolicited resumes from search firms or agencies for any job posting. Resumes submitted to any employee of Elevation Oncology by any search firm or agency without an applicable contract in place will be the property of Elevation Oncology and no fee will be paid.
-
Seniority level
Director -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Biotechnology
Referrals increase your chances of interviewing at Elevation Oncology by 2x
See who you knowFeatured Benefits
Inferred from the description for this job
-
Medical insurance -
Dental insurance -
Vision insurance -
401(k) -
Paid maternity leave -
Paid paternity leave -
Disability insurance
Get notified about new Director of Quality jobs in United States.
Sign in to create job alertSimilar jobs
People also viewed
-
Director, Quality Operations Management
Director, Quality Operations Management
-
Director, Quality
Director, Quality
-
Director, Quality
Director, Quality
-
Director of Underwriting Quality Reviews
Director of Underwriting Quality Reviews
-
Assistant Director QA GCP/GVP
Assistant Director QA GCP/GVP
-
Director, Quality & Control Assurance (Remote)
Director, Quality & Control Assurance (Remote)
-
Director, Clinical Quality Assurance (GCP)
Director, Clinical Quality Assurance (GCP)
-
Area Director of Quality
Area Director of Quality
-
QA Director
QA Director
-
Associate Director, QA Compliance
Associate Director, QA Compliance
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub