Director of Quality
4 weeks ago
This Jobot Job is hosted by: Victoria Casal
Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.
Salary: $165,000 - $210,000 per year
A bit about us:
Rare Disease Biotech based in Boston
Why join us?
Competitive Base
Full Benefits
PTO
401K with Match
Equity
Hybrid and Remote work schedules
Job Details
Job Details:
Our organization is seeking a highly motivated and experienced Permanent Director of Quality to join our team in the Scientific industry. The individual will be responsible for maintaining and enhancing our quality systems and ensuring compliance with global regulatory requirements. This role is instrumental in establishing, implementing, and maintaining the Quality Management System (QMS) in alignment with the company's strategic objectives. The ideal candidate will have a strong background in the scientific industry, a deep understanding of quality systems, and an unwavering commitment to excellence.
Responsibilities:
- Oversee the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory standards such as CAPA, GLP GXP, GxP, Document Control, SOPS, CMC, 21CFR, EU GMP, ICH, ISO, QSR, and cgmp.
- Develop and implement a robust CAPA system, ensuring prompt and effective corrective and preventive actions.
- Provide strategic direction and oversight for quality systems, ensuring alignment with business objectives.
- Collaborate with cross-functional teams to drive quality initiatives and improvements across the organization.
- Manage vendor oversight processes to ensure consistent quality and compliance.
- Lead and support clinical trials by ensuring quality and regulatory compliance.
- Ensure readiness for internal and external audits and inspections, and act as the primary liaison with regulatory agencies.
- Drive continuous improvement initiatives to enhance quality systems and processes.
- Develop and deliver quality training programs to enhance the understanding and compliance of staff with quality requirements.
Qualifications:
- Bachelor's degree in a scientific discipline. Advanced degree preferred.
- Minimum of 10 years of pharmaceutical/biotech industry experience in in the development and administration of quality systems supporting pre-clinical, clinical and commercial programs
- Minimum of 5 years of experience in a quality leadership role within the scientific industry.
- Extensive knowledge and experience with quality systems and regulatory standards including CAPA, GLP GXP, GxP, Document Control, SOPS, CMC, 21CFR, EU GMP, ICH, ISO, QSR, and cgmp.
- Proven experience in vendor oversight and management.
- Experience in leading and supporting clinical trials from a quality perspective.
- Excellent leadership and team management skills, with the ability to inspire and motivate others.
- Strong problem-solving skills and the ability to make sound decisions under pressure.
- Excellent communication and interpersonal skills, with the ability to interact effectively at all levels of the organization.
- Strong organizational skills, with the ability to manage multiple priorities in a fast-paced environment.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification preferred.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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