Project Manager, Regulatory Compliance Specialist, Operations Management

Senior Project Manager:
Manufacturing Transformation

Regulated Manufacturing / Technology Transfer / CMO and CDMO Transition

Location:

London (four to five days on site while the programme is established)  

Salary: £80,000 to £90,000, plus bonus

Contract:

Permanent   

About the role

Our client, an established and well regarded name in consumer health products manufacturing, is entering a significant period of operational transformation its manufacturing activity (internal production to external manufacturing partners) needs to be analysed and rationalised and the Project Manager will be central to making that happen.

This is not a project coordination or PMO role. The strategy is still developing, and the person appointed will help shape it into a practical, deliverable programme, then personally drive that programme through partner selection, technology transfer, validation, go live and stabilisation.

What you will own

Assess the current manufacturing model and the options for the future, building business cases and commercial comparisons to support decision making
Identify, evaluate and support selection of external manufacturing partners, including due diligence against GMP, quality and capability criteria
Own the programme roadmap, governance, budget, risk register and dependencies, reporting to senior stakeholders on a regular cadence
Lead technology transfer: process and specification transfer, trial and validation batches, packaging and regulatory continuity, and any dual running needed to protect supply
Manage cutover, stabilisation and formal handover to the ongoing operational and quality owners once the transition is complete
What we need from you

Proven ownership of a complex manufacturing, site transfer or technology transfer programme, from definition through to delivery, in a regulated manufacturing environment
Enough technical understanding of manufacturing and quality systems to engage credibly with Quality, Regulatory and manufacturing specialists, with or without direct CMO or CDMO experience
A formal project management qualification (for example APM, PRINCE2 or PMP), with evidence of applying it in practice rather than holding the certificate alone
Genuine commercial and financial literacy: comfortable building or interrogating a business case, modelling scenarios and understanding cost implications, not handing the numbers over to Finance
Strong stakeholder management and the confidence to challenge a plan or a senior stakeholder when you believe it is wrong, and to explain why
Relevant sectors include pharmaceuticals, consumer health, medical devices and Med Tech, healthcare products, FMCG, and food, supplements or nutraceuticals. What matters most is the complexity and regulatory demands of the environment you have worked in, rather than an exact sector match.

This role will not suit

A background in general programme or project management, for example in IT, financial services, construction or infrastructure, is not a fit here, however strong the delivery track record, unless it also includes hands-on ownership of a manufacturing, site transfer or technology transfer programme in a regulated environment. Familiarity with project management software or governance frameworks on their own is not what this role is looking for.

Next steps

This search is being handled confidentially on behalf of our client by Tracey Harris at Harris Lord Life Sciences. For a confidential conversation about the role, contact Tracey Harris at . HL123