About the role:
As External Quality Manager, you will play a key role in overseeing the Quality aspects of external manufacturing operations including Quality Agreements, audits, deviation management, and product lifecycle support - ensuring compliance and collaboration across Pharmanovias global supply partners.
Our ideal candidate will have experience within the pharmaceutical industry handling third party manufacturing organisations with a number of following disciplines: Quality Systems, Quality Operations, QC Laboratory, Analytical or Process Validation, Manufacturing, Production or Warehouse.
The department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.
Main responsibilities & duties:
- Write, review and negotiation of Quality Agreements and to ensure key responsibilities are documented
- Completion of assigned Quality Technical Agreements in line with project timelines
- Provide effective quality oversight of the Quality aspects of several contract manufacturing organisations during project phase and transition to business-as-usual
- Support planning and execution of audits of third parties
- Quality oversight CMO Deviations, Change Controls, complaints
- Support timely discussion of OOS results with other Quality/Technical staff
- Quality support for qualification of a new CMO
- Leading reviews investigations in a timely manner and timely escalations to the manager/QP as required
- Liaise with internal and external stakeholders as required to achieve timely completion of all CAPAs relating to customer & internal audit CAPAs
- Ensure oversight of the product stability set up activities for products
- Timely completion of ad hoc and other tasks as assigned
- Quality support for product technology transfer
- To identify, review and present any quality risk associated with product and escalate to project manager and line manager.
- Building the relationship with affiliate companies and CMOs for the designated products from Quality point of view
About you:
Candidates with progressive experience in managing CMOs across several disciplines within the pharma environment should have the skills and experience required for the role. We are also looking for:
- Bachelors degree in pharmaceutical sciences or equivalent, postgraduate degree or diploma is a bonus
- Lead Auditor Qualification (and additional Supplier Qualification is a plus)
- Excellent IT skills across all MS packages including Excel, Word, PowerPoint, Outlook, Teams
- Quality software skills (Trackwise, SAP) desirable
- Good working knowledge of current GMP, SOPs, EU GMDP guidelines and regulations and ICH guidelines
- Strong QMS elements knowledge and experience (Deviations, OOS, Investigations, CAPA, change management, complaints)
- Experience of manufacturing solid dosage forms, liquids, creams and sterile products
- Experience of routinely preparing and negotiating Quality Technical Agreements
- Experience of facilitating OOS and Root Cause Analysis
- Knowledge of GDP is desirable
- Experience of Technology Transfer and Nitrosamine risk assessment is desirable
- Precise and attentive to minute details while reviewing critical due-diligence documents to escalate the manager on product quality issue
- Ability to work on own as well as part of team, collaboration across cross-functional environments
- Ability to build strong professional relationships
- Excellent professional English communication skills, both written and verbal
What we offer:
We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.
By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
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Hope started operating in 2013 and we had a lot of positions that we needed to fill. We initially relied on recruitment agencies and did a little bit of our own direct advertising, but wanted to explore more cost effective recruitment methods. We decided to try some e-recruiters to see how they could help. Ortolan were by far the best and also the most cost effective of the suppliers that we tried and we now ask for their help with virtually all of our external recruitment needs, because they provide a very personal and tailored service, have people, rather than computers, working on their candidate searches and short lists. Using Ortolan has significantly reduced our expenditure on attracting candidates, but has also meant that we have had a much broader range of people applying to work for us than before. I d highly recommend trying Ortolan to see how they can help you.
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Chief Executive I am a solicitor who as well as having had a 10 year career as a British Army officer has also run a number of successful businesses. I have worked in large law firms, small start-up businesses and have been the CEO of a NASDAQ listed international leisure company. Drawing on this broad base of experience I co-founded Ortolan Group in 2007, driven by the opportunity to provide innovative and high quality recruitment services at a sensible price point. Today I help to manage the business and also spend a lot of time working as a solicitor with our sister company, Ortolan Legal. Because of my background, I tend to lead on all of our legal recruitment work. I occupy my spare time raising Tamworth pigs and flying.
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Senior Consultant Having spent most of my working life in Recruitment and HR, I sold my successful Recruitment Business in 2009 to a large national High Street agency. Having missed the recruitment industry too much to stay away! I joined Ortolan in 2013 and I now head up their Permanent Recruitment Division. I live in Cheshire with my husband and unruly pack of 4 very large dogs, and as I don t work Mondays love to spend long weekends out and about in the countryside with the dogs, and ever so occasionally shopping for handbags and shoes!
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Senior Consultant After attaining an engineering degree and working for British Gas designing distribution systems, I had a change of career and joined British Aerospace as a computer programmer. I then spent twenty years working for major IT solutions vendors in a range of roles (product and sales support, professional services, technical management), before I had my next change of career into recruitment in 2008, when I moved from South East to Derbyshire. In my spare time I like to explore the Peak District, then reward myself with a pub lunch!
