Pharmaceuticals

Director R&D Quality & Clinical Auditing

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About the job

 Are you a university graduate with demonstrated expertise and specific technical knowledge of the Clinical Trial areas subject to audit? Are you open to exploring a new exciting job opportunity? 

Invenia Group is partnered with a biotech multinational with a turnover of €40 billion and over 30,000 employees in multiple international sites. We are searching for a Director of R&D Quality and Clinical Auditing, to be responsible for the quality governance and auditing of clinical trials for their rapidly expanding pipeline spanning phase 1 through to phase 4.

This is a business-critical role that will see you leading a team of 8 Senior Managers and Associate Directors.

Role responsibilities:

If successful, you will develop and oversee Good Clinical Practices (GCP) audit strategy that aims at proactive identification of risk. You will support global GCP inspections and lead business critical inspections, influence in areas of impact to the company through an external focus on GCP legislation and inspection interpretation and lead a team that conducts GCP audits and collaborates with other GXP audit functions, as appropriate. You will also be responsible for the following: 

  • Defines GCP audit conduct and focus and provides oversight through the review and approval of audit plans and audit reports
  • Integrates the global perspectives to achieve the optimal GCP audit strategy in accordance with company objectives to proactively identify risk areas
  • Leads strategic audit planning based on risk assessments by RDQ TAQ and continuously innovates strategic approach
  • Recruits, trains, and directly supervises professional audit staff
  • Identifies and addresses succession-planning needs for all levels in the department
  • Manages and re-directs resources as necessary to assure that the company strategy and objectives of RDQ CTQA are achieved
  • Provides direction and oversight to the GCP audit program
  • Reviews results/analyses of GCP audits
  • Co-leads senior forums, such as Quality Oversight committees related to GCP
  • Influences anticipate and act on trends and changes in the international regulatory environment and new developments internally and externally
  • Translates strategy into operational goals and objectives
  • Defines outsourcing strategy for GCP audits, executes negotiations with vendors for the outsourcing of audits in this area and provides strategic directions, and supervises contract discussions
  • Provides direction and oversight to the coordination of external health authority inspections related to GCP
  • Support key regulatory agency inspections of high risk and impact to the company
  • Participate in Due Diligence teams to assess GCP areas and prepare clearly written, accurate, evidence-based reports to effectively communicate possible issues
  • Collaborates with industry colleagues through benchmarking of regulatory activities to establish a state-of-art program
  • Identifies new efficient processes for compliance operations
  • Provides oversight to assigned auditors
  • Prioritizes and focuses on matters of significance
  • Maintains in-depth knowledge of governmental regulations affecting GCP and the development of medicines
  • Builds and maintains strong audit relationships with the Quality Group in GCCCI
  • Influences on matters that affect quality and compliance in GCP activities

What we are looking for: 

We are looking for a University Graduate with a life sciences degree preferred. You should be a recognized expert in internal and external Quality, with a demonstrated expertise and specific technical knowledge of the Clinical Trial areas subject to audit, as evidenced by 15+ years in the industry.

You should have a minimum of 10 years of technical auditing and/or related experience, with an ability to participate in the critical evaluation of quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations, and understanding of legal and business aspects related to health authority inspections outcomes and a good understanding of the drug development processes.

This role also requires 15% international travel.

Sound interesting? To find out more information regarding this exciting opportunity, please apply.