Contract
Essex
Posted 3 weeks ago

Quality Manager – Clinical Trials – 12 Month FTC

Salary: Negotiable DOE + Up to 15% bonus + Pension + Private Healthcare + 25 days holidays + 8 bank holidays

Location: Site based in Bishop Stortford

Contract type: 12-month FTC

The requirements of the Quality Manager:

  • You will already have 3+ years’ experience working as a Quality Manager, Head of Quality, Quality Team Leader, QA Manager with direct reports in a Clinical, Biotech or Pharmaceutical environment
  • Must have experience with, and implementation of cGMP’s, GLP, GCP, calibration, and validation
  • You will have a Life Sciences degree or equivalent in a scientific field
  • Extensive experience working in an MHRA regulated environment
  • Strong experience of ISO 9001 and EU GMP quality standards
  • Experience of HTA/HFEA and EUTCD regulations to a Designated Individual/Person responsible level
  • Knowledge of GMO regulations, European Clinical Trials Directives & Regulations to a Responsible Person level
  • Ability to solve issues and recommend/implement appropriate changes
  • Excellent interpersonal, customer focused, problem solving, and planning/organization skills
  • Excellent attention to detail, ability to read and interpret general procedures and governmental regulations and follow up in a timely manner
  • Ability to write reports and business correspondence and effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Willingness to travel within the UK and abroad & possesses a Full UK driving licence and valid UK passport

The role of the Quality Manager:

  • The Quality Manager oversees the quality management system to ensure it is suitable, adequate and effective to support all applicable EU GMP Quality System Regulations, ISO 9001 and European Union Tissues and Cells Directive
  • Fosters a quality culture to achieve site-wide program success through measurable activity, metrics, and strong ability to influence teams in the areas of focus
  • Responsible for effective internal audit program, management reviews, quality procedure development, continuous improvement of the QMS and training of personnel on the quality system processes
  • Coordinates external audits for ISO registration, as well as UK regulatory inspections; coordinate responses to customers’ supplier questionnaires
  • Responsible for the CAPA and complaint handling systems, and maintains quality metrics related to product/process quality and customer allegiance
  • Assists with and follows-up on non-conformances, investigations, complaints, etc. Assures that issues are resolved in a timely manner and corrective actions are implemented and monitor effectiveness to prevent recurrence
  • Evaluates and develops techniques designed to maintain awareness of SOP’s, and cGMPS’s
  • Develops and directs quality improvements
  • Escalates quality events (as necessary) and works with personnel to periodically review significant aspects of operations related to quality
  • Quality sponsor and interacts with customers on quality issues and is an advocate on the company’s quality concept
  • Implements and monitors key performance indicators (KPI’s)
  • Provides or assists on employee training to ensure compliance with procedures and regulations
  • Designated Individual for HTA License, Person Responsible for HFEA License, Responsible Person for the MHRA: responsible for IMP and Specials licenses
  • Responsible for release of unlicensed product
  • Supports GLP compliance as required
  • Responsible for all required Quality Technical Agreements
  • Overall responsibility for the Quality Assurance and Quality Control departments including Validation and all contracted Qualified Persons
  • Travel Circa 20% & occasional travel to Europe is also required

The Company:

  • My client is a true market leader across the life sciences sector
  • Their product range is vast and un-rivalled within the industry not only for its broad range but the true quality of the products which they offer
  • With particular focus on customer satisfaction, they retain business at an extremely high rate and have a firm majority of the market share in a variety of markets as a result

Apply today by sending your CV to Oliver Gill of Langton Howarth Ltd via email to olivergill@langtonhowarth.com or call Oliver in confidence right now for more information on 0113 243 3499 OR 07792 488 206.

You must have the right to work in the UK to be considered for this role

Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate’s name and contact details in confidence via email too, and we’ll ensure you receive £100.00 of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.

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