Background and Experience
Mark King is a highly successful, innovative and engaging senior quality leader, passionate about patient safety and continuous improvement. He has over 30 years of pharmaceutical industry experience in delivering improvements in UK/EU/US GMDP and quality culture across multiple dosage forms and facilities.
Mark has extensive experience of leading successful GMDP Inspections from different competent authorities, performing global supplier GMDP audits across the supply chain, as well as acting as the quality lead during multiple mergers and acquisitions.
Through high levels of rapport and trust, Mark has the ability to consistently build and maintain collaborative relationships, in culturally diverse settings, with internal and external stakeholders.
Mark has also worked as a Senior Quality Consultant providing GMDP expertise to a wide range of clients based in the UK, EU, US, India and China.
Outside of his direct industry experience, Mark jointly established the British Generics Manufacturers Association (BGMA) / MHRA Quality forum which he chaired for a 3-year term.
- Chartered Biologist
- Eligible Qualified Person under the permanent provisions
Qualified...
A Qualified Person under the UK permanent provisions since 2001 and named on both MIAs and MIA-IMPs, Mark has acted as QP assessor since 2005 and is the former Vice Chair and Chair of the QP assessors panel for the Royal Society of Biology (RSB).
Mark is eligible to be named as a QP on MIA/MIA-IMPs in UK and EU, and as an RP/RPi on GB WDA(H)s.
Take Your Next Step with Mark King Quality Pharma
We are here to provide expert quality and GMDP consultancy support when you need it most.
Please submit your enquiry.
Services
Expert GMDP Consultancy covering QA / QC.
- With extensive QA and QC experience, we deliver a broad range of high-quality sustainable solutions based on extensive hands-on experience.
- In addition, we have access to a wide network across the industry and are therefore able to recommend and collaborate with other trusted experts.
MHRA GMDP Inspection Preparation / Support / Responses / Remediation including MHRA CMT/IAG support.
- We provide mock MHRA GMDP inspections, including coaching for the teams involved, best practice recommendations on running the documentation room and managing the inspection process.
- We can deliver support with pre inspection compliance reports, interim compliance reports and responses to inspection deficiencies and in supporting the closure of any remediation action(s).
- We can also provide support for companies under the MHRA compliance escalation process including Inspection Action Group (IAG).
UK MHRA Defective Medicines Report Centre (DMRC) support.
- We provide support with DMRC notifications and addressing associated actions.
Supplier GMDP Audits - full supply chain.
- We perform GMDP supplier / service provider audits covering the global supply chain. These audits can be for cause, routine or to support supplier selection.
Pharmaceutical M&A Quality due diligence.
- We can provide support and strategic advice for M&A activities. Including performing data room reviews, remote/onsite GMDP audits and risk ranked reports. This service covers products and/or facilities, including for virtual companies.
- We have experience of engaging with and advising multidisciplinary stakeholders.
Contract QP services.
- Eligible to be named as a QP in the UK and IE on an MIA or MIA-IMP.
Contract RP / RPi Services.
- Eligible to be named as RP/RPi on a WDA(H) in GB.
Quality / Qualified Person Education.
- As a former QP assessor and Vice Chair / Chair of the RSB assessment panel, Mark offers trainee QP mentoring , coaching and mock viva sessions.
- Bespoke Quality / GMDP education.