Head of Quality Operations
Salary details available on discussion + excellent benefits package
My client are a leading global pharmaceutical company based in Hertfordshire who due to company growth and on-going expansion are currently seeking an experienced Head of Quality Operations and QP to join their business on a permanent working basis. The company have over 10,000 employees globally and currently have a focus on two main therapy areas with a number of exciting products. Having recently announced a large investment in their UK operations, this position will be responsible for the operational scale up and management of the manufacturing plant and procedures as well as the operational management of the Quality Assurance and Quality Control departments.
If you are looking for the opportunity to develop yourself, departments and grow an expanding packaging and manufacturing facility then this could be just the role for you. With excellent internal progression opportunities and the opportunity to step in to a role with commercial and operational oversight, now really is the time to get in contact to explore further.
The role will be responsible for directly line managing the Quality Assurance and Quality Control departments and will take responsibility for all Quality activities related to the development and progression of said departments. As the Head of Quality Operations for their leading Manufacturing site which includes manufacturing, packaging, testing, storage and distribution functions.
This broad leadership role, will see you responsible for overall operational management of the quality function to GMP standards; people management of 2 direct reports and a wider 29 in-direct reports; actively perform duties as a QP for the site; support the global GMP audit program as well as work cross functionally with both manufacturing site & wider stakeholder teams (e.g. clinical trials) at local and EMEA regional level and external parties (e.g. Audit bodies, CMOs).
Other key responsibilities will include:
• Leadership of the QA/QC Operations team
- Responsible for batch disposition and oversight of batch release processes
- Main Quality contact for operational teams across the site.
- Management of key quality processes in partnership with operations, including batch disposition, QC testing, stability program, deviation and CAPA management, on-time delivery, schedule adherence, product supply, risk assessments and change control.
- To support the ongoing compliance of the manufacturing facility. Including implementation of new GMP requirements. Raising initiatives to improve compliance with current GMPs. Ongoing training, coaching and mentoring of all staff in GMP and compliance.
- To manage all staff ensuring that job descriptions, objectives and appraisals are up to date.
- To support the recruitment and training of staff for the QA and QC functions and design and implement systems and procedures to support their development.
- To design and implement systems and procedures for the efficient, productive, compliant and safe operation of the production operation.
Successful applicants must be able to demonstrate excellent management/leadership experience as well as 5+ years of hands on releasing QP experience (Ideally within OSD), within a manufacturing environment.
You must also be able to show:
• The ability to establish and maintain effective working relationships with internal and external stakeholders.
• Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.
• Demonstrated knowledge, understanding and application of GMP guidelines and regulations.
• Fluent English communications skills (written & spoken).
- Ability to interpret complex data and present key findings.
To apply for this role, please call Bob Beevers at CPL Life Sciences on +44 7890 551 627 or send an updated version of your CV via email to email@example.com
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.
- Agency: Clinical Professionals
- Contact: Bob Beevers
- Reference: JO-2101-460471
Website: Clinical Professionals
- Posted: 8th January 2021
- Expires: 5th February 2021