What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You are the named person who signs off that batches may be sold, or that a distributor is operating properly — but you are not employed by the company you sign for.
You certify batches against the marketing authorisation and good manufacturing practice, or you oversee a wholesale distribution authorisation, as a named individual on a client’s licence. The contract governs the commercial relationship; it does not divide the accountability.
You are the point where a company’s entire chain of evidence is judged by one person who does not report to it — which is precisely why the law names an individual rather than an organisation.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Named on a client’s manufacturing or wholesale distribution authorisation, without being employed by the holder of it.
NAMED · PERSONALLY ACCOUNTABLE ON A CLIENT LICENCE
Working across clients
The eight facets above describe a role inside one organisation. Contract Qualified Person / Responsible Person is not in one, so these are the boundaries that replace a reporting line.
WHOSE SYSTEM GOVERNS
The client’s, in full — but with a constraint no other cross-client role carries. Under Article 48 of Directive 2001/83/EC the manufacturing authorisation holder must have the qualified person permanently and continuously at their disposal, so a contract arrangement has to deliver genuine continuous availability rather than scheduled visits.
AUTHORITY
- What the client must fix before a batch can be certified
- Where a deviation or investigation is insufficient to support certification
- Whether the client manufactures, tests or investigates the way you would prefer
- Whether the client accepts commercial loss caused by a refusal
- Anything that would let another person certify on your behalf — under Article 51 and Annex 16 the certification is personal
BETWEEN ENGAGEMENTS
- Your eligibility and the qualifications that support it
- Judgement about what evidence is sufficient to certify against
- Client batch records, deviations and investigation detail
- Knowledge of one client’s failures, into an assessment of another’s
- Certification entries in the client’s register that carry your name after the contract ends
- The written rationale for any batch you declined to certify
- Certifying batches at a site whose quality system you were paid to design
- Holding named positions at so many sites that continuous availability at each becomes a claim you cannot substantiate
- Accepting a contract whose terms make refusal commercially impossible — the ability to refuse is the function
- Manufacture, testing and review by the client’s own staff
- Release of the batch to market
- Distribution under the client’s authorisation
- Evidence generated by people who do not report to you
- Genuine and continuous access to the site, its records and its deviations
- A contract that gives you the standing to refuse
- The authorisation holder, for every certification decision
- The client’s commercial supply chain
- The certification decision, personally and non-delegably
- The decision to refuse or to stop
- The manufacture or the testing you certify against
- The client’s procedures and their maintenance
- The commercial consequence of a refusal
- The authorisation holder’s management, in writing
- The regulator, and resignation from the named position, where a client will not resolve a matter you cannot certify around
- The certification register entry, or the equivalent record the law requires
- A written record of the basis on which certification was given or refused
WHAT THIS ROLE CAN EVIDENCE · 0
No published competency maps to Contract Qualified Person / Responsible Person yet. 14 are published across the registry, and this role is not among the ones they name.
Read the standard and its stated coverage →A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Quality Assurance pathway. No scenario exercises this role yet, so Practise comes later for it, then what any of it evidences. Skip any of them — the order does not change.
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 211Current Good Manufacturing Practice for Finished PharmaceuticalsFDA · last revised 2023-04-01
- ICH Q9(R1)Quality Risk ManagementICH · last revised 2023-01-18
- ICH Q10Pharmaceutical Quality SystemICH · last revised 2008-06-01
- ISO 9001:2015Quality Management Systems — RequirementsISO · last revised 2015-09-15