EU Importation Manager & Qualified Person (QP), Open to flexible working
We are seeking a Qualified Person (QP) to join our Market Supply and Distribution Quality team within the EU Importation Operations function.
The role reports into a Quality Director and provides EU/UK batch certification and release service to GSK's Principal Trading Companies (PTCs) and Trading Partners. You will ensure compliance with the GMP aspects of the laws governing the importation of products into the EU / UK in relation to all batch-releases. As a leading member of the OQ team you will be able to work with a degree of autonomy making critical Quality decisions whilst mentoring and supporting colleagues. In addition to undertaking regular batch release activities you provide direct support for critical deviations (including attending incident management meetings). The role will involve regular interaction with cross functional colleagues so stake-holder management, whilst acting with the highest level of integrity, respect and transparency is critical.
A key element of the role is to manage risk/mitigation in relation to Brexit.
The scope of the role also includes provision of support to other GSK divisions responsible for commercial activities (currently including; GSK Trading services, GSK Export, Consumer Trading and ViiV Trading services).
Key Responsibilities (include, but not limited to):
- Lead operations to allow EU/UK certification of batches of pharmaceutical products imported by the Principal Trading Company (PTC). This includes supporting management of any incidents to ensure supply sites have the information required to lead investigations and resolve incidents.
- Ensure the Importation operation is inspection ready and participate in regulatory inspections of the QP certification process on behalf of the PTC.
- Perform Audits of the importation supply-chain (compliant to GMP, GDP and MIA authorization).
- QP certify all batches of pharmaceutical products imported into EU / UK in accordance with all applicable laws and guidelines (eg; EU Guidance on GMP Part 1, Annex 16).
- Act as key point of contact with non-EU / UK based GSK manufacturing sites (and with GSK external supply quality and GMP audit teams) for products manufactured outside the EU / UK to ensure QP certification requirements are maintained.
- Act as a key point of contact with R&D for new products being imported into EU / UK ensuring a testing location is identified and resourced (as required) and QP certification and release activities meet programme timelines.
- Co-ordinate with the PTC Quality Manager for QMS implementation, Quality Councils, Controlled drug licenses and Resource management.
Location - Please note: The role can be based at any GSK site in the UK, but please note that there is a requirement to travel to Barnard Castle (County Durham) to review and approve batch-release (as the need arises). It is anticipated that this will be circa 3 to 4 times a month.
You will be a qualified QP (Qualified Person) who has sound knowledge of global, regional and national regulatory requirements and GMP guidelines (including risk management). Knowledge/experience relating to Brexit would be advantageous. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset.
CLOSING DATE for applications: Monday 10th of May 2021 (COB).
When applying please use your CV to describe how you meet the proficiencies for this role. The information that you provide in your CV will be used to assess your application.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world.
- Qualified Person (QP) qualification.
- Relevant experience (eg; knowledge/experience of batch-release and Brexit-related process and guidelines).
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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