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Consultancy outcome GMP / GDP Netherlands-based, worldwide support

Interim QA, QP and RP leadership that leaves the quality posture in place

An interim PCS partner doesn't just fill the seat—they install the quality posture the role demands and leave it in place after handover. Compliance becomes part of how the site operates, not a binder the next leader inherits.

260+ organisations
500+ audits
10,000+ trained

PCS team

Your PCS consultants for this engagement

  • Jaap Koster

    Jaap Koster

    CEO of PCS

    Founder of PCS, 43+ years pharma experience across NA, SA, Asia, Africa, Europe

When this is the right fit

Specific situations where an interim PCS partner earns their fee:

Your QP, RP, or QA Director seat has just gone vacant and batch release is at risk within 4 weeks

You just received a 483 or critical inspection finding and need senior oversight before the response window closes

A remediation programme has missed two consecutive milestones and needs an owner with decision authority

Batch release and deviation escalation decisions are routinely sitting unresolved for more than 5 working days

Your senior quality leaders are spending more than half their time firefighting instead of governing

You need the next permanent hire to inherit a working system—not the same backlog the last leader left

When this is NOT the right fit

We turn down work that doesn't match how we operate. Be honest with us if any of these describe the brief:

You need a body in the seat to keep an org chart legal, with no expectation of system change

You are sourcing the lowest day-rate option—our model is senior partners, not staff augmentation

You want an interim to sign batches without challenging the underlying release process

You are looking for a compliance certificate without changing operational behaviour

What you get

A senior partner in the seat from week one, decisive governance, and a quality posture that stays in place after the interim leaves.

Stabilisation and control plan

Rapid assessment of current risks, priorities, and decision bottlenecks—translated into a clear stabilisation plan and cadence.

Governance and decision ownership

Clear roles, escalation pathways, and meeting routines that ensure timely decisions and traceable oversight.

Execution leadership

Senior leadership for remediation, inspection readiness, and cross-functional delivery—aligning QA with Operations and Engineering so quality stops being treated as a separate function.

Capability transfer

Coaching and structured handover so your organisation becomes stronger and more self-sufficient after the interim period.

How we work

Choose the delivery format that fits urgency and governance expectations.

Rapid start (1–2 weeks)

Stabilise and prioritise

Stabilise and prioritise

Typical deliverables

  • Fast onboarding and risk review
  • Decision bottleneck mapping (release, deviations, change control)
  • Oversight framework and escalation rules
  • Immediate focus on inspection and product risk
Embedded interim (1–3 days/week)

Lead and deliver

Lead and deliver

Typical deliverables

  • Interim QA leadership / project QA leadership
  • Chair governance, approvals, and escalation pathways
  • Drive remediation execution and progress reporting
  • Coach team leads and key SMEs
Transition & handover

Make it stick

Make it stick

Typical deliverables

  • Role handover plan and knowledge transfer
  • Team capability uplift (coaching + targeted training)
  • Sustained governance and KPI rhythm
  • Exit criteria and "stay in control" plan

Typical timeline

1

Partner conversation (30 minutes)

A senior partner aligns with you on role scope (QA/QP/RP), urgency, the real risk picture, and where decision ownership is currently breaking down.

2

Scope confirmation (48 hours)

You receive a clear interim scope, cadence (days/week), responsibilities, and start plan—aligned with your governance and stakeholders.

3

Delivery (weeks 1–12+)

Stabilise operations, lead key decisions and programs, and transfer capability—while keeping inspection readiness and quality oversight intact.

What clients see

Example (anonymised)

A site faced a sudden leadership gap during a remediation period and increasing inspection pressure. PCS embedded interim leadership, stabilised governance, accelerated decision-making on deviations and change control, and guided the team through readiness activities—ensuring continuity and a controlled handover to permanent leadership.

See more clients and outcomes →

Frequently asked questions

Often yes. We can typically start with a triage call immediately and confirm an onboarding plan within days, depending on availability and scope.

It’s leadership with delivery. We cover critical responsibilities while improving governance and enabling your team to run the system sustainably.

Yes—often a hybrid model. On-site for key governance moments and shopfloor alignment, remote for follow-ups, reviews, and reporting.

Yes. Interim roles often work best when combined with focused remediation, coaching, and capability transfer so improvements remain after handover.