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Find where you are

A “You are here” map for each GxP role we cover — what surrounds your work, what you own, what you don’t, and what you escalate. Read it at your altitude.

48 ROLE MAPS PUBLISHED · ALL EARLY-CAREER · FREE, NO ACCOUNT REQUIRED

WHAT EVERY MAP CONTAINS · EIGHT FACETS

COMES AFTER (UPSTREAM)
COMES BEFORE (DOWNSTREAM)
YOU DEPEND ON
DEPENDS ON YOU
YOU OWN
YOU DO NOT OWN
YOU ESCALATE TO
EVIDENCE YOU CREATE

How to use this library

Start from the practice you work in, then narrow by the kind of organisation or the industry if that is how you think of your job. Read the map at your altitude: what surrounds the work, what you own, what you do not, and what you escalate. Filter to the roles that have a scenario if you want something to practise.

Maps run from associate roles to named-accountable and specialist roles; none yet covers managing a function. A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.

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48 role maps

Presentation order

Qualified Person for Pharmacovigilance (QPPV)The named individual personally responsible for a marketing authorisation holder’s pharmacovigilance system in the European Union. Named to the authority, resident in the Union, and answerable in person — which is a different kind of accountability from managing a department.2sectorsPharmacovigilance

Clinical Sample ManagerOwns the chain of custody for specimens taken from trial subjects, from the moment of collection to analysis or destruction. The sample is the only physical evidence a trial produces, and it cannot be re-collected.4sectorsClinical Operations

Veterinary Pharmacovigilance SpecialistMonitors the safety of medicines given to animals — where the patient cannot describe a symptom, the reporter is usually a vet or an owner rather than a clinician, and one of the outcomes being watched for is harm to the human handling the product.2sectorsPharmacovigilance

Cosmetics Quality ManagerRuns manufacturing quality for cosmetic products, where the standard is ISO 22716 rather than a pharmaceutical GMP code and there is no approval step downstream to catch what the plant misses.3sectorsQuality Assurance

Veterinary Product Quality LeadOwns quality for medicines and medicated feed given to animals, where the patient cannot report a problem and part of the safety case is about people who eat the food-producing animal later.3sectorsQuality Assurance

Cosmetics Safety AssessorSigns the safety conclusion for a cosmetic product before it is placed on the market. In the EU this is a named, qualification-gated responsibility rather than a job title an employer can simply assign.3sectorsRegulatory Affairs

Excipient Quality ManagerRuns quality for materials that are not active and not inert. ICH Q7 governs active ingredients, which is precisely why excipients needed a guide of their own.3sectorsQuality Assurance

Bioanalytical Laboratory ScientistMeasures drug and biomarker concentrations in samples taken from trial subjects. The samples are clinical, the analysis is laboratory work, and the standard that applies is neither pure GLP nor pure GCP — which is the confusion the role has to navigate.3sectorsLaboratory & Quality Control

Founder or Principal InvestigatorMoves a discovery out of the laboratory toward a regulated product, usually with no quality organisation and no colleague to ask. The first regulated obligations arrive well before there is anyone hired to hold them.1sectorsRegulatory Affairs

Data Integrity LeadOwns whether the organisation’s records can be trusted as evidence. The work is not about storage or security — it is about whether a result can be reconstructed years later by someone who was not there.4sectorsComputer System Validation

Environmental Monitoring SpecialistMeasures whether the controlled environment is behaving as qualified. The data is not a pass mark on a batch — it is evidence about a state of control that a single result can never establish on its own.4sectorsLaboratory & Quality Control

CAPA and Quality Systems ManagerRuns the system that turns problems into changes. The measure of the role is not how many actions close on time — it is whether the same problem comes back.4sectorsQuality Assurance

Training and Qualification LeadEstablishes that people are competent to do GxP work, which is a different claim from establishing that they attended training. The regulation asks for the first and most systems record only the second.4sectorsQuality Assurance

Regulatory Strategy LeadDecides the route a product takes to market and defends it as the evidence changes. Distinct from regulatory operations, which executes submissions — this role chooses what to submit, where, and when.2sectorsRegulatory Affairs

Medical WriterTurns study data into the documents regulators and clinicians read. The document is a regulatory record, so what it may say is bounded by what the data supports — which is the constraint the role is there to hold.2sectorsClinical Operations

Independent GxP ConsultantAdvises across many clients and many subjects, holding no quality system of their own. The authority is to recommend; the decision, the system and the consequence stay with the client.6sectorsQuality Assurance

Notified Body AuditorAssesses manufacturers’ conformity on behalf of a designated body. Neither a regulator nor a consultant — and the role is defined as much by what those two comparisons rule out as by what it does.1sectorsMedical Device Quality

Certification Scheme ManagerRuns the certification scheme itself — auditor competence, impartiality, and the structural separation between the people who assess and the people who decide.1sectorsMedical Device Quality

Clinical Research CoordinatorRuns the trial at the site. Turns a protocol into visits that actually happen, with consent and data that will still stand up when someone reads them years later.1sectorsClinical Operations

Clinical Research Associate (Monitor)Monitors investigator sites on the sponsor’s behalf. Verifies that what the records say happened actually happened — while never running the site and never fixing it.3sectorsClinical Operations

Clinical Site Quality LeadOwns quality across a site running many sponsors’ trials at once — where each sponsor arrives with its own expectations for one set of staff, one set of facilities and one set of records.1sectorsClinical Operations

SaMD Quality LeadHolds quality for software that is itself the medical device — where the release cadence software culture expects meets a regime designed around physical product.1sectorsMedical Device Quality

Vendor Validation EngineerWorks at the software supplier, producing the evidence regulated customers need to validate a product the supplier itself does not operate.3sectorsComputer System Validation

Compounding PharmacistPrepares a medicine for an identified patient need that no manufactured product meets. The authority comes from pharmacy practice law and the compendial chapters — not from a manufacturing licence, which is the distinction the whole role turns on.1sectorsManufacturing Operations

Sterile Compounding TechnicianPerforms aseptic preparation at the bench. The product cannot be tested into compliance after the fact, so technique — demonstrated, requalified and observed — is the control.1sectorsManufacturing Operations

Serialisation SpecialistMakes each saleable unit individually identifiable and keeps that identity intact through packaging, distribution and every trading-partner handoff. A regulated outcome delivered almost entirely through computerised systems.2sectorsDistribution & GDP

Packaging EngineerDesigns and qualifies the pack that has to protect the product, carry the approved labelling, and survive the supply chain it will actually meet rather than the one it was designed against.2sectorsManufacturing Operations

Contract Qualified Person / Responsible PersonNamed personally on someone else’s authorisation. The inverse of a consultant: the client owns the system, and the individual carries an accountability that does not transfer when the contract ends.3sectorsQuality Assurance

Contract AuditorAudits suppliers and runs mock inspections for hire. Full authority to find and none to fix — and no stake in whether the finding is ever closed.5sectorsQuality Assurance

Service-Provider Quality Lead (CRO / CDMO)The provider side of the sponsor relationship. One quality system that must satisfy many clients’ expectations at once, and absorb each of their audits.3sectorsQuality Assurance

Quality Assurance AssociateThe early-career role inside the independent quality function — reviewing records, supporting deviations and change control, and learning release from the inside.2sectorsQuality Assurance

Computer System Validation AnalystThe early-career role in computer system validation — planning and documenting the risk-based validation of GxP software so systems are fit for use and their electronic records are trustworthy.3sectorsComputer System Validation

Manufacturing OperatorThe role that executes and documents manufacturing steps contemporaneously — the first line of both product quality and data integrity on the floor.2sectorsManufacturing Operations

Laboratory Analyst (QC)The role that runs analytical or microbiological tests to validated methods and records results with full integrity — the data behind every release decision.3sectorsLaboratory & Quality Control

CQV EngineerThe role that executes commissioning and qualification protocols (IQ/OQ/PQ) and documents the evidence that facilities and equipment are fit for use.2sectorsEngineering & CQV

Process EngineerThe engineer who owns the robustness of the manufacturing process itself — supporting scale-up and technology transfer, monitoring process performance and continued verification, and leading the technical investigation of process deviations.2sectorsManufacturing Operations

Clinical Data CoordinatorThe role that manages clinical trial data quality — case report forms, queries, and reconciliation — toward a clean, defensible database lock.2sectorsClinical Operations

Regulatory Affairs AssociateThe role that compiles and maintains regulatory submissions, tracks commitments, and supports regulatory intelligence and change impact.2sectorsRegulatory Affairs

QC MicrobiologistThe early-career role in the microbiology laboratory — running bioburden, endotoxin, sterility, and environmental-monitoring tests to validated methods, and holding the contamination-control evidence behind sterile assurance.3sectorsLaboratory & Quality Control

Distribution Quality SpecialistThe early-career role in distribution quality — extending Good Distribution Practice past the site boundary: temperature-excursion assessment, lane and transport qualification, and distribution deviations.1sectorsDistribution & GDP

Pharmacovigilance AssociateThe early-career role in drug safety — intaking, triaging, and reporting adverse-event cases under Good Pharmacovigilance Practice, keeping the post-market safety signal flowing.2sectorsPharmacovigilance

Technology-Transfer EngineerThe early-career role in manufacturing science and technology (MSAT) — running technology transfer between development and commercial manufacturing through gap assessments, transfer protocols, and comparability.2sectorsManufacturing Operations

Supplier Quality AssociateThe early-career role in supplier quality — qualifying and monitoring suppliers and contract organisations through quality agreements, audits, the approved-supplier list, and supplier change control.3sectorsQuality Assurance

Internal Auditor (Quality Systems)The early-career role in the internal audit programme — planning and conducting risk-based audits independent of the areas audited, and verifying corrective-action effectiveness.3sectorsQuality Assurance

Design Assurance EngineerThe early-career role holding the quality evidence around a device design — requirements traceability, verification and validation, and the risk file that has to stay true as the design moves.2sectorsMedical Device Quality

Complaint & Vigilance SpecialistThe early-career role running the post-market feedback loop for devices — complaint intake and investigation, reportability decisions, and the trending that turns individual events into a signal.1sectorsMedical Device Quality

Food Safety & Quality AssociateThe early-career role working the preventive-controls system on a food or dietary-supplement site — monitoring at the control points, verifying sanitation, and keeping the records that show a hazard stayed controlled.2sectorsFood Safety & Quality

Sterility Assurance SpecialistThe early-career role behind the technical case that a sterile product is sterile — environmental monitoring, media fills, sterilisation and depyrogenation cycles, and the contamination-control strategy that ties them together.3sectorsLaboratory & Quality Control

COMPLETE INDEX — ALL 48 ROLE MAP

Every count on this page is derived at render — practice from each role's graph node, organisation and industry from the role's own record, the pathway from the same record, and the scenario count from the scenarios that reference it.

WHAT IS NOT PUBLISHED

The 48 maps run from associate roles to named-accountable ones such as the QPPV and the contract QP. There is no map yet for managing a function or leading at executive level, so if you lead a team the nearest published thing is the comparison of what each organisational level owns and escalates — which is a different question, and we would rather say so than file you under a role you do not hold.

Responsibility at every organisational level →