JOB DESCRIPTION
Piper Life Sciences is currently looking for a Head of Quality in Montgomery County, MD to work for a cutting-edge biotechnology company developing and delivering innovative technologies for the prevention of infectious diseases.
Responsibilities for the Head of Quality Include:
- Lead the development and maintenance of an integrated global quality management system
- Monitor of compliance and access impact of regulatory changes on corporate policies
- Lead quality audits and ensure implementation of revised improvement plans
- Coordinate with GxP team to assure clinical and manufacturing sites are in a state of inspection readiness
- Access and communicate quality and compliance risks to leadership
Qualifications for the Head of Quality Include:
- 15+ years’ experience in Quality Assurance
- Demonstrated experience designing and implementing Quality Management Systems across an organization
- Expert knowledge of regulatory issues and inspections, specifically with the FDA and EMA
- Ph.D. or Master’s degree in pharmaceutical, biologics, or related field
Compensation for the Head of Quality Includes:
- Salary up to $220,000 plus annual bonus based on experience and education
- Full Benefits: Medical, Dental, Vision, 401(k) plan, Holidays, PTO
Keywords:
Quality assurance, QA, QC, quality control, gcp, cgcp, gmp, cgmp, FDA, EMA, MCC, regulatory, quality management, pharmaceutical, pharma, combination device, biotechnology, regulatory, benefits, vacation, holiday, 401(k)
