Leiter der Herstellung and Leiter der Qualitätskontrolle: the two documented GMP seats under § 12 AMWHV

Ask about named roles in German pharma manufacturing and everyone points at the Qualified Person. Fair enough, that appointment carries the batch release signature. What gets overlooked is that the same plant runs on two other defined functions, and that most people who eventually reach the QP seat pass through one of them first.

Neither has the drama of a statutory appointment notified to an authority. Both decide how a site actually works. I write this from 16 years recruiting in pharma, where sorting out who really owned what inside a production site explained more about a candidate's seniority than any job title on the contract.

Where the two roles come from

The German anchor is § 12 AMWHV, the provision on personnel in leading and responsible positions. It requires the area of responsibility of the sachkundige Person to be laid down in accordance with § 19, and it does the same for the heads of production and quality control: their responsibilities are documented, in writing or electronically.

Above that sits Chapter 2 of the EU GMP Guide, the chapter on personnel, which describes the same two functions as key personnel and sets out their duties in more detail. German inspectors read both, which is why a job interview for either seat tends to move quickly from your CV to what you would sign off and what you would refuse to.

What the head of production owns

Products are manufactured and stored according to the appropriate documentation. Manufacturing instructions are approved and followed. Production records are checked. Premises and equipment are maintained. The necessary process validations happen. Staff receive initial and continuing training that matches what they do.

In a working week that turns into the tension every production lead knows. The schedule wants throughput, the batch record wants completeness, and a deviation raised at four in the afternoon can stop both. The people who grow into this seat are the ones who can hold the line on the record without becoming the person who blocks everything.

What the head of quality control owns

Approving or rejecting starting materials, packaging materials, intermediates, bulk and finished products, and doing it against specifications the same function has approved. Approving test procedures and other quality control instructions. Approving and monitoring contract laboratories. Keeping test facilities and equipment fit for purpose. Making sure the required testing is carried out and validated. Training the staff who do it.

The word that carries the weight is rejecting. This is the function whose signature keeps material out of the process, and the authority to say no is exactly what the independence requirement protects.

The independence rule, and why it shapes careers

§ 12 AMWHV requires the leadership of production and the leadership of quality control to be independent of each other. One person cannot hold both.

That single sentence explains a lot about how sites are structured, and about how your record is read. A career that has always sat on one side of the line is normal and expected. What impresses is being able to describe the other side accurately, because it shows you can work the interface rather than fight it. § 12 also points out what a site adds when it markets finished products: a Stufenplanbeauftragter and an Informationsbeauftragter have to be designated as well, which is how mid-sized companies end up with several named functions sitting on very few people.

How they relate to the sachkundige Person

The QP certifies and releases the batch. The two heads run the systems that make certification possible. In small and mid-sized companies the same individuals often appear in more than one of these definitions, in larger ones the functions are staffed separately with deputies.

For your planning the useful reading is this: quality control leadership is the most common step before a sachkundige Person appointment, because the analytical evidence and the specification history already run through the seat. Production leadership is the more common step toward site management. Both are documented positions, so both belong on a CV with the dates you actually held them.

Who is hiring

Every site with a manufacturing authorisation needs the two functions covered, which spreads demand from large originator plants to contract manufacturers, generics sites, biologicals, sterile manufacturing, packaging operations and the small specialists making niche dosage forms. Chapter 2 of the EU GMP Guide states that key positions should normally be full-time, so part-time constructions and thin coverage attract questions in an inspection. Contract manufacturing has been the most active hiring corner in recent years, and it is also where a candidate can accumulate a wider product range faster than at a single-product site.

What a CV has to evidence for these roles

Write which of the two functions you held, with the dates, and say explicitly that the responsibility was documented, because that is what § 12 AMWHV asks a company to be able to show. Then the substance: dosage forms and technologies, batch sizes, whether the site was sterile or non-sterile, which markets it supplied, how many staff reported to you, which authority inspected it and what came out of it. For quality control, name the analytical methods and the validation work rather than only the instrument list. For production, name the process validations and the deviation and CAPA load you carried. Applicant tracking systems match the German strings, so Leiter der Herstellung and Leiter der Qualitätskontrolle belong in the document literally; the mechanics are in my guide on the ATS in pharma.

A note on salary

I will not quote a band. Pay for both functions depends on site size, technology, shift structure, how many people report to you, and whether the role is combined with another documented responsibility. Sterile manufacturing pays differently from packaging, and a contract manufacturer with twenty customers is a different job from a single-product plant. Ask what else sits on the position before you compare two offers, because these seats are where companies quietly stack responsibilities.

Frequently asked questions

Can one person be both head of production and head of quality control?

No. § 12 AMWHV requires the leadership of production and the leadership of quality control to be independent of each other, which rules out holding both.

Does the AMWHV prescribe a specific degree for these roles?

The provision sets out the responsibilities and the independence requirement rather than a named qualification. In practice, sites staff both functions with natural science, pharmacy or engineering backgrounds and the supervising authority looks at whether the person can actually carry the documented responsibility.

How do these roles relate to the Qualified Person?

The sachkundige Person certifies and releases the batch, and § 12 AMWHV points at § 19 for how that area of responsibility is laid down. The two heads run production and quality control themselves. Quality control leadership is the more common stepping stone toward a QP appointment.

Do these functions have to be full-time?

Chapter 2 of the EU GMP Guide states that key positions should normally be occupied by full-time personnel. Deviating from that is possible in principle but it becomes a question in an inspection, so small sites tend to solve it with clearly documented deputies.

Sources

§ 12 AMWHV, personnel in leading and responsible positions (gesetze-im-internet.de, German)
AMWHV, full text (gesetze-im-internet.de, German)
EudraLex Volume 4, EU GMP Guide, Chapter 2 Personnel (European Commission)
§ 14 AMG, manufacturing authorisation (gesetze-im-internet.de, German)

© 28 July 2026 Andreas Schulz. All rights reserved. This article is career guidance, not legal advice; the statutory text prevails.