Reference Number: JO-2006-450812
Director QA, Immunolgy
Job Type: Permanent
Director of QA, Immunology and Director of QA, Internal Manufacturing
Salary details negotiable + excellent benefits package
My client is a dynamic and growing global pharmaceutical company headquartered in Stockholm who are currently seeking an experienced Quality Director, Immunology and Quality Director, Internal Manufacturing to join their business on a permanent working basis. The company have around 1400 employees globally and currently have a real focus on two therapy areas with a number of exciting products.
If you are looking for the opportunity to develop yourself, a team and a department then this could be just the role for you. With excellent internal progression opportunities and the opportunity to be part of the global QA senior leadership team with commercial and operational oversight, now really is the time to get in contact to explore further.
The roles will be responsible for quality operations including product release to market, internal manufactured products and release of manufactured drug substances as well as line management of the department along with full budget responsibility. You will take responsibility for all Quality activities related to the development and progression of said department to include; design, development, delivery and execution of the Global QA strategy including audit and inspection management, QMS management, product release and to take a lead on the assurance of compliance for all projects, products and programs. PLEASE NOTE: These roles will require an experienced QP to release products to market.
Other key responsibilities will include:
Ensure products, processes, systems and procedures are in compliance with relevant authority requirements including FDA, EMA ICH etc and global company procedures.
Provide strategic and operational leadership for your own team and Global Quality department including resource planning, budget responsibilities and HSE.
Responsible for QP release (as named on the manufacturing licence) of products within your area of responsibility and that delegate QPs are trained.
Host and respond (including follow-up) on audits and Health Authority inspections, including handling recalls etc within quality.
Successful applicants must be able to demonstrate management experience as well as strong understanding of pharmaceutical QA, QP experience within a Biotech environment ideally as well as experience of both developing audit procedures, to include hosting and conducting across local and global regions as well as QP release experience.
You must also be able to show:
The ability to establish and maintain effective working relationships with internal and external stakeholders.
Extensive/demonstratable knowledge of Quality Assurance pharmaceutical procedures.
Demonstrated knowledge, understanding and application of GMP guidelines and regulations.
Fluent Swedish communications skills (written & spoken).
Ability to interpret complex data and present key findings.
To apply for this role, please call Bob Beevers at Clinical Professionals on +44 207 822 1710 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.