Head of Quality

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)
  3. United States
San Diego, USA
Posting date: 10 May 2021

*This position requires being onsite in San Diego. Please only apply if you are local or okay with relocation to the area*

Exciting time to join a clinical-stage company in sunny San Diego that focuses on cell therapy/regenerative medicine!

Job Responsibilities:

  • Provide creative resourceful guidance to Management, the Quality team and Project teams.
  • Manage, communicate across, up and down the organization as needed to inform and align priorities.
  • Strong planning, organization, communication, presentation skills.
  • Manage, motivate, mentor direct reports and Quality team members, to higher levels of capability.
  • Delegate responsibilities to Quality team members to promote engagement and growth.
  • High level resource planning, ensure optimum utilization of resources available.
  • Harmonize change management and design control for biologic and device components.
  • Promote cGMP quality standards to be understood and embraced throughout the organization.

Personal Attributes:

  • Ability to understand and communicate detailed scientific, quality, and regulatory information.
  • Strategic thinker with the ability to influence at all levels of the organization.
  • Strong inspirational leadership skills as a change agent.
  • Highly organized, experienced risk assessment and risk management skills.
  • Results-oriented focus on business objectives and goals.

Skills and Requirements:

  • Minimum 15-20 years' Quality experience in Biopharma Quality/CMC
  • Experience in developing and managing Phase 3 Quality System.
  • Quality function leadership 30+ people required
  • Quality Control management experience
  • Biologics experience. Cell therapy, medical device and/or combination product experience a plus.
  • Direct experience with health authority inspections.
  • Proficiency in Good Clinical Practices to support Clinical QA is desired, not mandatory.

If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.