Do you have experience establishing and tracking metrics, compliance monitoring and developing Standard Operating Procedures (SOPs)?

Are you looking for an opportunity to ensure appropriate Good Clinical Practice (GCP) and Pharmacovigilance (PV) systems are implemented?

Are you located in Palo Alto, California, or are you willing to relocate?

Fraser Dove International is partnering exclusively with an innovative organisation specialising in developing drugs to treat rare diseases. Operating worldwide, they are committed to making a difference in patients’ lives.

Our client is seeking a successful leader to take responsibility for the GCP and PV Regulatory Compliance strategy in an established organisation. This individual will also serve as a member of the Extended Leadership team of the Quality Assurance (QA) organisation.

Discover more about our Senior Director GCP and Pharmacovigilance Regulatory Compliance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Senior Director GCP and Pharmacovigilance Regulatory Compliance, you will be measured against the following objectives:

1) Leading a team that is responsible for GCP and PV Regulatory Compliance of Clinical Development.
2) Establishing and executing global GCP and PV processes, standards, and compliance monitoring systems.
3) Ensuring compliance with all corporate policies, global regulations, guidelines and internal procedures within Development Operations and Global PV.

What you will do:

As the Senior Director GCP and Pharmacovigilance Regulatory Compliance, your duties and responsibilities will include:

  • Ensuring GCP and PV Inspection Readiness and continuous process improvements.
  • Collaborating with internal and external stakeholders to ensure appropriate GCP and PV systems are implemented.
  • Reviewing and analysing audits, inspections and CAPA data to identify compliance trends.
  • Providing compliance expertise on GCP and PV strategies, programmes, processes, and activities to help manage risk.
  • Developing and maintaining GCP and PV procedural documents.
  • Periodically reviewing SOPs to determine the need for changes.
  • Reviewing, monitoring, and trending root cause analyses from non-compliance metrics.
  • Performing impact assessment of changes in new GCP and PV regulations and guidance on current practices and processes.
  • Partnering with the Global QA team to determine GCP and PV best practices.

What you will bring:

These are the skills and experience you will need to succeed as the Senior Director GCP and Pharmacovigilance Regulatory Compliance:

  • Exceptional communication skills and ability to collaborate with others.
  • First-rate attention to detail and capability of seeing the bigger picture.
  • Strong decision-maker and the ability to make practical, compliant decisions.
  • Demonstrated sound-judgement and analytical skills.
  • Excellent planning, time management and organisation skills.
  • Minimum of 12 years’ experience in GCP and/or Pharmacovigilance in the pharmaceutical industry.
  • Bachelor’s degree in a scientific discipline.

What you will get:

These are the perks and benefits that will complement your generous base salary:

  • Medical and dental insurance.
  • 401k plan.
  • Car/travel allowance.
  • Annual bonus.
Got what it takes?

To apply for the Senior Director GCP and Pharmacovigilance Regulatory Compliance, click the ‘Apply’ button below or contact the Executive Search Consultant – Dan Eastwood – on +44 (0)203 355 7050.

Please Note:
  • This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

If you’re exploring executive opportunities in the life sciences, get in touch with our executive search consultants, upload your CV or apply for our life science executive jobs.