Associate Director, Quality Assurance

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
York, North Yorkshire
Posting date: 28 Feb 2019

ProClinical is partnering with a leading biotechnology company to advertise a vacancy for a Associate Director, Quality Assurance position. This organisation is a recognised leader in medical diagnostic and global clinical trial testing services and is seeking an applicant to join their UK based team.

The Associate Director of Quality Assurance will partner strategically with operational leadership to promote and support a culture of audit readiness within the company's Global Laboratories. They will oversee a quality assurance team responsible for Quality Issues (QI) process, Audit/Inspections, Corrective Action & Preventive Actions (CAPA), proficiency testing & training, and Standard Operating Procedure (SOP) management whilst reporting to the Sr. Director, Quality Assurance.

Job Responsibilities:

  • Manage all aspects of quality assurance including audit/inspection process, QI tracking, and CAPA process.
  • Leading large-scale projects that drive quality throughout the organization.
  • Liaising with clients and regulatory bodies to ensure we meet and exceed expectations.
  • Supporting the operation in process improvement initiatives; developing Standard Operating Procedures (SOPs) to support the QMS.
  • Developing, implementing, and delivering Inspection Readiness, Root Cause Analysis, Compliance and other critical training initiatives to support the operation.
  • Leading a team that partners strategically with site leadership to promote and support an 'audit-ready, all the time' culture.
  • Assisting in developing and monitoring Quality Assurance departmental budget.
  • Managing staff - planning, assigning, & directing work, appraising performances, guiding professional development, rewarding & disciplining employees, addressing employee relations issues, and resolving problems
  • Participating in Continuous Professional Development
  • Providing oversight to the documentation, reporting, effectiveness checks & closure of compliance issues
  • Providing oversight of the internal audit program.
  • Monitoring the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulations
  • Independently providing oversight to and performing a wide range of activities to support the Quality Assurance department by providing guidance and oversight to the processes. required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organization.
  • Partnering strategically with Quality Assurance Senior Leadership Team.

Skills and Requirements:

  • A Bachelor's degree is required.
  • 7 years of experience in quality assurance; experience in a laboratory, pharmaceutical or clinical research setting preferred.
  • 3 years in progressive leadership experience required; experience managing global quality assurance and/or regulatory affairs preferred.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Prepared to work hard to meet ambitious deadlines and exceed clients' expectations
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tom Russell at +44 203 826 1331 or upload your CV on our website -

A full job description is available on request.

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