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Director GCP Compliance

  • Job type: Permanent
  • Location: California
  • Salary: Negotiable
  • Job reference: 280191/002_1552052844
  • Sector: Clinical Operartions, EPM Scientific
  • Date posted: 08/03/2019

JOB: Director or Senior Director GCP Compliance

LOCATION: Newark, California

JOB TYPE: Full time

COMPANY: Small Bio-Tech

This is an amazing Director/Senior Director of GCP opportunity at 200-person biotech company in the San Francisco Bay area. Their pipeline centers primarily around aesthetics (both injectable and topical) and they have a lead product that is currently in late clinical stages. This company strongly values their employees beyond just a salary and your basic 401k, medical, dental, and vision. The care extends to flex spending, great stock options, bonuses, free weekly meals, gym plans, even a tuition reimbursement program.

This company is small and really is looking for a great cultural fit who is willing to wear multiple hats. This is a great opportunity to grow out your own GCP Team and perfect Quality Management Systems. They are really looking for someone to make their mark on this quality leadership team.

Essential Functions include:

- Implement and lead GCP compliance function

- Establish QMS system

- Manage, plan, and oversee daily routine for consultants and auditors

- Plan, schedule, and facilitate audits of external vendors, and clinical sites.

- Create and identify mitigation plans for projects

Preferred Skills:

-Extensive Knowledge of Drug/ Medical Device/ Biologics GCP and industry regulations

-12 years' experience in Pharmaceutical, Device, or Diagnostic industry

-Successfully completed PAI

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