Interim & Fractional QA / RA Leadership
Senior quality and regulatory leadership exactly when you need it — to fill a gap, steer a critical period or build a function from scratch — without the time and cost of a permanent hire.
A vacant Head of Quality or Head of Regulatory role is a real business risk. Batches wait for release, submissions slip, inspections approach without clear ownership and teams lose direction. Recruiting the right permanent leader can take months, and early-stage companies often do not yet need one full time.
Radical Pharma Consultancy provides experienced quality and regulatory leaders on an interim or fractional basis. Our consultants have held senior QA and regulatory roles in pharmaceutical companies, so they can step in quickly, earn the confidence of your team and regulators, and focus on what matters most.
Whether you need full-time cover for a few months or a few days a month of senior oversight, we tailor the engagement to your stage and priorities.
Leadership Services
Interim QA Director / QA Manager
Full or part-time leadership of your quality function during a vacancy, transition or critical period.
- Day-to-day leadership of QA operations
- Batch and document review oversight
- Inspection hosting and follow-up
- Management review and quality metrics
Fractional Head of Regulatory
Senior regulatory direction for companies that need strategic leadership but not a full-time executive.
- Regulatory strategy ownership
- Agency interaction planning and oversight
- Submission planning and vendor management
- Board and investor regulatory updates
Staff Augmentation
Experienced professionals to add capacity for projects, backlogs and peaks in workload.
- Deviation, CAPA and change-control backlogs
- Submission and dossier projects
- Audit programmes and supplier qualification
- Document remediation projects
Team Mentoring & Training
Leave behind a stronger team, not just completed tasks.
- Coaching new or developing QA and regulatory leads
- Structured knowledge transfer and handover
- Role-specific GxP and regulatory training
- Support for recruiting your permanent leader
How an Engagement Works
Discover
We discuss your situation, the gap to fill, priorities, reporting lines and the time commitment you need.
Match
We propose a consultant whose background fits your products, stage and markets, and agree objectives for the first 30–90 days.
Lead
Your interim leader integrates with your team, takes ownership and reports progress against agreed objectives.
Transition
We document, hand over and support your permanent hire or in-house team so progress is sustained.
When Clients Call Us
- A Head of Quality or Regulatory has left and recruitment is under way
- A start-up needs senior oversight but not a full-time executive yet
- An inspection, launch or major submission is approaching
- A merger, acquisition or restructuring is changing the organisation
- A new team needs experienced leadership and mentoring
Leaders Who Have Done the Job
- Senior QA and regulatory careers at Mylan, Auro Pharma, AstraZeneca, Pfizer and GSK
- Experience leading through inspections, submissions and launches
- Flexible models: full-time, part-time or a few days per month
- Remote, local or on-site support across Canada, the US, the UK and the EU
- A focus on building your team's capability for the long term
Common Questions About Interim Leadership
How quickly can an interim leader start?
Often within a few weeks, depending on availability and the scope of the role. We will give you a realistic start date during our first conversation.
What is the difference between interim and fractional leadership?
Interim leadership typically covers a role full time or close to it for a defined period, for example during recruitment. Fractional leadership provides senior expertise for a set number of days per month on an ongoing basis — ideal for early-stage companies.
Can the interim leader work remotely?
Yes, many responsibilities can be delivered remotely. For activities such as inspections, batch release oversight or team building, we agree an appropriate on-site presence.
Will the interim leader help recruit a permanent replacement?
Yes, if you wish. We can help define the role, review candidates from a technical perspective and support a structured handover.
How is interim leadership priced?
Interim and fractional roles are typically priced on a day-rate or monthly retainer basis, agreed up front after a free discovery call.
Often Combined With
Let's Talk About Your Leadership Needs
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