Head of Quality / RP / QP
An international pharmaceutical company is seeking to recruit a new Head of Quality/RP/QP to their Cambridge based office. The organisation specialises in improving drugs, repurposing drugs, and reinstating generic drugs, all by underpinning formulation technology. This position offers an exciting opportunity to work with a company that is dedicated to giving patients great freedom and choice.
The Head of Quality will be responsible for all aspects of Quality Assurance and Quality Control for the business, ensuring successful delivery of business strategy and that policies, procedures, and projects meet appropriate regulatory standards within a model where the majority of operations are outsourced internationally. The Head will also ensure the efficient and effective day to day running of the department whilst acting as the Responsible Person for Good Distribution Practice or training to become an RP.
- Developing and implementing the Quality department's strategy to ensure that it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.
- Monitoring all Quality Assurance systems to ensure compliance with Commission Directives.
- Maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements.
- Ensuring regulatory compliance with appropriate and required licences and legislation.
- Maintaining and improving departmental operational performances to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs), and external and internal customers, with respect to quality, service, lead time, and cost.
- Ensuring the development of departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
- Ensuring that all activities are performed in accordance with GMP, company SOPs, and Health and Safety policies.
- Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team (SMT).
- Preparing, reviewing, and approving Technical and Quality Agreements.
- Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved).
- Leading, training, and developing the existing Quality team.
- Taking the lead in regulatory inspections, customer audits, and internal audits.
- Undertaking any other duties as expected of the Head of Quality position.
Skills and Requirements:
- Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
- Eligible to be a Qualified Person under permanent provisions in accordance with directive 2001/83/EC as amended.
- An impressive and demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Good understanding of the pharmaceutical market.
- Wide knowledge of products and processes used in the outsourced manufacture of medicines.
- Demonstrable project management skills.
- 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.
- Proficiency with computer skills, such as MS Office.
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 Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.
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.
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