Quality leadership vacancy: how to organise cover

Identify the decisions that cannot wait

Start with work that cannot wait until the vacancy is filled. This may include quality assessments, document approvals, open deviations or responses already promised. Separate preparing a document from assessing its content and formally approving it. These activities do not necessarily belong to the same person.

Create one list showing the item, deadline, possible consequence of delay and authorised decision-maker. Verify dates against the actual obligation: an internal preference and a binding deadline require different treatment. If the responsible approver is missing, show that explicitly as an unresolved issue.

Senior management should then decide which capacity will be provided and what takes priority. Do not conceal a vacancy by adding every responsibility to someone already at capacity. The first useful result is a workable allocation of responsibilities, not an artificially complete status report.

Distinguish quality leadership, quality control and QP duties

This article addresses EU GMP Part I for human medicinal products. In everyday language, “quality leadership” may refer to different functions. Establish which role is actually absent using the organisation chart, job description and applicable requirements. A title such as quality management representative does not by itself establish the required qualifications or authority.

EU GMP Chapter 2, sections 2.1–2.6, addresses adequate resources, clear responsibilities and corresponding authority. Duties of responsible personnel may be delegated to designated deputies with appropriate qualifications. The heads of Production and Quality Control must remain independent. Qualified Person duties have a specific boundary: they may be delegated only to other Qualified Persons.

Assess each decision being transferred individually. Project management experience does not automatically make someone an authorised approver. Site authorisations and national requirements also need consideration. The following working aids do not replace that assessment.

Record the assignment, boundaries and access

Document the cover arrangement in a way people can use during daily work. This table is a practical suggestion, not a prescribed regulatory form. Integrate it into your existing quality system.

Confirm acceptance of the responsibilities and communicate the arrangement to the affected departments. A document filed in a personnel folder does not, by itself, resolve questions in operations.

Prioritise the backlog by its consequences

Sort open work by the next necessary decision and its possible impact. An old formatting correction may be less urgent than a new issue affecting product quality. Ticket age is useful information, but it is not a sufficient prioritisation method.

Record the rationale for significant priority decisions. Where quality impact is uncertain, the responsible function assesses it through the established procedure. Do not allow unresolved risks to disappear behind a green project status. A progress discussion should expose pending decisions, rather than merely count completed tasks.

Delegate operational work while preserving role boundaries

Support can often be defined as a concrete work package: collect records, reconcile a document inventory, structure evidence gaps or prepare a draft for technical review. Define inputs, the expected output, reviewer and completion criteria.

For example, existing requirements, test records and open points can be organised for selected validation activities. The output is a reviewable overview with explicitly identified gaps. The responsible function assesses the content, and formal approval comes from the authorised person. External preparation does not itself constitute approval.

Daniel Herrmann Consulting can support these bounded tasks and their coordination. This does not promise appointment as a QP, quality management representative or interim quality leader. We establish the appropriate service from the actual assignment. The compliance capacity gap page explains how work can be organised when internal resources are limited.

Make authority usable in daily work

After appointing the deputy, walk through a real item from receipt to decision. Can the person find the current document? Is the required information available? Does escalation reach the right contact? Can the person act in the relevant system within their authority?

Provide access for the assigned duties and record its allocation through the established procedure. Use personal permissions rather than the absent employee’s account. Conversely, system access does not establish professional approval authority. Check these two dimensions separately.

Inform affected interfaces, including Production, Quality Control, IT, project teams and external partners where relevant. Name the contact and the route for unresolved decisions. Under EU GMP Chapter 1, senior management retains responsibility for an effective and adequately resourced pharmaceutical quality system. Operational cover should make that responsibility actionable.

Plan the handback from the beginning

A temporary arrangement needs an ending that does not depend on individual memory again. Maintain a short decision record during the cover period: what was decided, on what basis and where is the evidence? Include unresolved matters, changed priorities and promised follow-up activities.

On return or recruitment, assign open tasks explicitly. Review responsibilities, deputy arrangements and access again. Also record the structural capacity gaps exposed by the vacancy. If resources remain insufficient, changing a name on the organisation chart will not resolve the issue.

Senior management benefits from a simple overview: decisions still pending, their owners and the capacity needed. That turns an individual’s overload into an organisational assignment that can be managed. Agree who keeps this overview current after the temporary arrangement ends.