Job Description
Job Description
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly and is positioned well for an exciting future of continued expansion.
We are seeking a detailed orientated, collaborative and process driven Quality Manager - Central Process and Systems who will lead a highly skilled Quality team of 6 across the UK and South Africa. This is a very exciting and newly created role which will enable you to make an impact and make your mark as we go through our global transformation.
The Role:
- Manage quality personnel, ensuring job descriptions, objectives, personal development plans and appraisals are up-to-date and completed on time.
- Build and manage a high-performing, collaborative team that always works in line with the Group’s values.
- Ensure that operations are carried out within the Quality team are completed in accordance with the requirement of the GxP regulations and guidelines, Clinigen Quality systems and industry standards.
- Establish, maintain and govern the process for managing client, regulatory and internal audits at Clinigen and host audits where appropriate.
- Govern the completion of client, regulatory and internal audits observations and CAPAs to ensure timely completion.
- Establish, maintain and govern the process and global procedures for the electronic Quality Management System (eQMS).
- Oversee and support the primary eQMS admin support for the business.
- Establish, maintain and govern the process and procedures for the learning management system (LMS).
- Ensure that systems, procedures and a program to manage the validation or qualification of premises, equipment, processes and computerised systems is in place.
- Support implementation of electronic systems as required, ensuring systems are rolled out in a compliant manner and work with external partners.
- Effectively manage the operational tasks within the Quality Management System (QMS).
- To manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance.
- Maintain awareness of issues surrounding falsified medicinal products.
- Identify and support the implementation of improvement opportunities, collaborating with the business areas, to form a strong and effective operational excellence team dynamic.
- Maintain Clinigen paper and electronic records for quality documentation.
- Take ownership to pro-actively develop your own capability and learning journey.
Key Requirements:
- Life Science degree or equivalent.
- Substantial experience within the pharmaceutical industry
- A strong working knowledge of GMP and GDP.
- Experience of MHRA inspections and general auditing.
- Knowledge of Unlicensed Medicines (Specials).
- Proven ability of accurate and timely completion of tasks.
- Adaptable to changing situations, with a proactive positive, flexible, assertive, can-do attitude
- Good influencing and stakeholder management skills
- Strong written and verbal communication skills
- Able to influence and lead by example, clearly communicating plans and results, promoting ownership and encouraging a collaborative approach to achieve solutions
- Able to delegate and prioritise effectively, considering individual and team strengths and development areas
- Ability to work with tight deadlines in a dynamic environment, delivering high quality outputs with strong attention to detail
Benefits:
- 27 days holiday plus 8 bank holidays
- Discretionary Bonus Scheme
- Pension contributions 5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
Interested? We would love to hear from you, please apply today for consideration.