The jobholder is responsible for leadership and oversight of external and internal service lines at Horsham covering CSOS, CAM, Comparator and ensuring smooth implementation of new service offerings.
The role will be responsible for assuring compliance with all relevant legislation and maintaining a best in class quality system.
The role is responsible for communication, building relationships and driving improvements for the clients both internally and externally.
- To establish, build and maintain the relationships with Global Quality and the horsham based teams for the existing service lines of CAM, Comparator & CSOS.
- To successfully integrate and implement new service line offerings at Horsham in a controlled manner ensuring all quality aspects are captured.
- Work to lead times keeping focus on the customer, client and ultimately the patient.
- To support Validation, Change and project work in the business unit
- To report, escalate and resolve issues as they arise within the Global Quality Service lines.
- To author, department approve or Quality Approve SOPs linked to the department.
- To complete self inspection and supplier audits as relevant/directed.
- To author, or approve Change control, deviations, complaints, audit actions as appropriate.
- To act as an SME for these areas, and present as requested to clients.
- To work via business development and service lines to ensure that the FCS Quality is engaged with the customer to ensure that Quality is a service differentiation for FCS.
- Ensure any global changes for service lines are in compliance with EU GMP requirements and are implemented in a controlled manner at Horsham.
- Drive integration between Quality and service lines.
- Identify and monitor service line specific trends and escalate internally to drive improvement.
- Ensure consistency and continuity of support for clients and escalate issues to senior management as required.
- Provide temporary intensive quality support to specific clients as required by business
- Other tasks as necessary to maintain the effective functioning of the client and supplier management activities across site as required by the Quality Director.
- Develop, define and manage the Quality Lead process
- Act as the Quality Lead for one or more major revenue earning clients.
- To liaise with the assigned clients relating to any Quality related issues
- Act as Delegate for Quality Director as required
Minimum Requirements/Qualifications: (Bullets)
- Degree Level or Equivalent in relevant subject or minimum of 5 years’ experience within Quality
- Professional Qualifications within the quality arena
Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
- Qualified Auditor preferred
- Extensive knowledge of GMP environments.
- Knowledge of the clinical trial supply chain process globally.
- Teamwork especially in a matrix management organisation. Ability to influence across functions across Fisher sites and across companies to achieve objectives.
- Process analysis skill suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit.
- Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction. Needs to be comfortable with ambiguity.
- Able to analyse problems and define solutions.
- Good communication skills both internally and externally. Ability to understand the clients requirements and to be able to devise and articulate the most appropriate solutions.
- Creativity – ability to be confident and convincing at highest level within the client organisations.
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