Job Title:  Head of Compliance (QP)

Role Details

Head of Compliance (Qualified Person)

Role: Full time, Permanent

Location: Fawdon, Newcastle upon Tyne

Salary: Competitive + bonus + benefits

The Role

Supporting the Director of Quality in maintaining and continuously improving GMDP standards at the Fawdon facility you will ensure current and future EU/UK GMDP requirements are met and that an effective Pharmaceutical Quality system is maintained.

You will build in house know how, capacity and capability within the quality team to support business growth whilst supporting a common Quality Culture and Accord everyday business behaviours to support collaborative working relationships between operations and quality functions.

Leading site inspections and communications with Regulatory Authorities related to GMDP you will support the Quality Management Review process and reporting the site quality performance to senior management and oversee continuous improvement activities to develop and enhance compliance – work with key stakeholders to build a continuous improvement environment and support an ongoing program of change.

To perform the Qualified Person duties in accordance with Directive" 2001/83/EC (amended by Directive 2004/27/EC) and following the guidance laid down in Annex 16 of Eudralex Volume 4 – Good Manufacturing Practice. ( desirable)

To carry out the routine duties of a Responsible Person in accordance with the EU GDP Guidelines 2013/C 343/01 and to ensure that all conditions of the Wholesaler Distribution Authorisation (WDA) are met.

The Person

• Degree in science discipline
• Qualified Person under the permanent provisions (desirable)
• Experience in working as a qualified person within manufacturing facilities, including batch certification 
• A detailed understanding and experience of Biologics and Sterile manufacture and packing and related product transfers 
• Experience of importing and certifying products from outside EU
• Experience of hosting MHRA GMDP Inspections
• A decisive thinker and able to progress actions to a schedule
• A practical approach to developing and implementing procedures and processes within a regulated environment
• Strong network of pharmaceutical quality professionals
• An excellent communicator, who can interact effectively on a global level and at all levels within the company

The Rewards

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

How to Apply

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 15/06/25. For more information, you can contact us on: careers@accord-healthcare.com

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide. 

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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