Regulation meets capacity pressure. An unfilled site, quality or tech-transfer lead is not a resource problem but a leadership problem. We fill your bottleneck functions in GMP production precisely and discreetly.
Regulation meets capacity pressure.
ANDRIS Consulting is a specialised executive search firm for pharmaceutical production and GMP manufacturing in the CDMO space. As headhunters for GMP and CDMO mandates, we fill leadership and selected key positions in in-house pharmaceutical manufacturing and contract manufacturing, in tech transfer, in quality assurance and in quality control. Our clients are pharmaceutical companies, contract manufacturers and CDMOs with GMP operations or pharma-adjacent production, such as food supplements and medical devices, as well as raw-material suppliers and specialised packaging companies.
The market for pharmaceutical contract manufacturing demands a quality of leadership it did not require before. EMA and FDA are raising inspection pressure on European sites at the same time, while reshoring mandates and new biologics pipelines push production capacity to its limits. CDMOs and in-house operations have to do both at once: scale up and stay audit-ready.
This is not a resource problem. It is a leadership problem. An unfilled site head, a missing Head of Quality Assurance or a vacant tech-transfer lead can, in extreme cases, halt the entire production and costs money every day. ANDRIS Consulting fills these positions precisely, discreetly and at eye level with the passive top profiles who would never have applied to a job posting themselves.
Two forces, one stress test.
In 2025 the global CDMO market reached a volume of around 150 billion US dollars and is growing at a CAGR of more than 7 percent. Behind this figure lie two opposing forces that put European CDMOs, contract manufacturers and in-house production sites under maximum pressure at the same time.
On one side, research-based pharma companies are increasingly outsourcing production. More than 60 percent of development and production contracts for new biologics and biosimilars now go to CDMOs. The reason is economically compelling: fixed costs are converted into variable costs, CapEx is externalised, risk is transferred. For the contract manufacturer this means full utilisation and maximum margin pressure at once. Added to this is the technological shift toward complex modalities, from monoclonal antibodies through antibody-drug conjugates to cell and gene therapies. These pipelines require single-use systems, new bioprocessing lines and highly complex tech-transfer capabilities.
On the other side, geopolitical realities are forcing a historic reshoring. In early 2026, more than 500 supply-relevant medicines were officially reported as being in short supply at the BfArM. The EU Critical Medicines Act aims to structurally break the dependence on Asian active-ingredient suppliers, currently at 60 to 70 percent. API production and fill and finish are to return to Europe under time pressure. Sterile fill capacity is nowhere near sufficient for this: around 35 percent of European CDMOs already report significant bottlenecks in fill-and-finish capacity.
The German GKV cost-stabilisation act of April 2026 adds further pressure. The newly introduced dynamic manufacturer rebate structurally hits patent-protected products and makes investment calculations harder. An exception applies to newly launched medicines whose active ingredient is produced in Germany, a deliberate incentive for domestic pharmaceutical production.
Annex 1, FDA, no margin for error.
European CDMOs and in-house production sites face the most severe regulatory turning point in 15 years. With the last grace period for lyophilisers expiring in August 2024, the revised EU GMP Annex 1 is fully binding. The mandatory Contamination Control Strategy, the use of barrier technologies such as isolators and RABS, PUPSIT requirements and seamless process validation force older legacy plants into multi-million-euro retrofit projects during ongoing 24/7 operation. Without specialised site and project leadership, costs and downtime escalate.
In parallel, the US FDA has massively increased inspection pressure after the post-Covid backlog. 42 percent of all CDER inspections in 2025 took place outside the US. Inadequate failure investigations and the failure of the Quality Control Unit under 21 CFR 211.22 are, according to the CDER report, regularly among the most common findings in Form 483 observations. According to analyses by the ECA Academy, data integrity is the most frequently cited finding in FDA warning letters, appearing as the central finding in more than 50 percent of the cases reviewed. The requirements of 21 CFR Part 11 and the ICH Q guidelines form the wider framework against which quality organisations are measured every day. The direct consequence of failure: loss of US market access.
Which functions save the margin?
Outsourcing pressure, Annex 1 compliance and FDA inspection density meet, in every plant, a limited number of functions that decide between a working operation and a standing line. Four positions decide the most operationally.
Four chairs. One empty is enough.
If one of these functions stays unfilled, the line can come to a standstill. ANDRIS Consulting fills them on a permanent and interim basis, with profiles who bring together patient safety and commercial reality, not mere compliance administrators.
Four positions where it is decided.
Four functions decide whether a plant delivers or stands still. We fill them all, on a permanent and interim basis, in Germany and across the DACH region.
A site head in a CDMO does three things at once: keeps the commitments to sponsors, keeps the plant audit-ready and steers parallel investment projects. Day to day, that mainly means keeping two KPIs high that have nothing to do with each other. On-Time-In-Full shows the sponsor whether the plant can be relied upon. OEE shows how efficiently the line runs when it runs. Add to that Right-First-Time across all batches, Time-to-First-Batch when ramping up new lines, and the speed at which tech transfers reach commercial production. A site head who keeps OTIF and OEE high at the same time is the exception rather than the rule. Those are exactly the profiles we fill.
The Head of Quality Assurance decides almost single-handedly whether an FDA or EMA audit goes well. A clean Contamination Control Strategy under Annex 1 is not a document QA writes on its own. Microbiology, engineering, production and QA have to carry it together. On the QC side, the same applies to data integrity. Missing audit trails, shared system access and manual interventions in electronic records lead directly to Form 483 observations and, in the worst case, to a warning letter with an import ban into the US. ANDRIS Consulting fills Head of Quality, Head QA and QC as well as Chief Quality Officer at CDMOs, sponsors and suppliers across the DACH region.
The tech transfer lead, in larger structures often called Head of MSAT, is the bridge between sponsor and own production. Three questions are practically always on the table: can we make the product at all? Can we transfer the process cleanly into our line and validate it? Can we own the process for the long term after the transfer? If this role is missing or too weakly staffed, every transfer takes longer than necessary. Typical pitfalls are poorly defined critical process parameters, a faulty method transfer of the analytical methods, and scale-up effects that were still inconspicuous at pilot scale. Benchmarks from the BioPhorum Operations Group show that biologics tech transfers typically take 18 to 24 months, considerably longer without a dedicated function. ANDRIS Consulting fills Tech Transfer Managers and Heads of MSAT at CDMOs and sponsors in Germany and the DACH region.
The Qualified Person is the last line of defence. As long as no QP is in place, no batch can be released. In a plant with only one QP, an unplanned vacancy is not an HR issue but a direct cash-flow problem. On an aseptic fill line with high-value products, it quickly comes to six- or seven-figure amounts per day, depending on what is currently in the line.
What troubles many managing directors is a lack of pragmatism. What is needed is a QP who cleanly distinguishes between critical GMP defects and non-critical observations, who works at eye level with the site head and justifies risk assessments in the concrete product context. A deviation in a parenteral sterile batch carries a different patient risk than the same deviation in an oral OTC tablet. ANDRIS Consulting fills Qualified Persons under § 14 AMG on a permanent and interim basis, at CDMOs as well as at research-based pharma companies. Specialised HR benchmarks indicate vacancy times of more than 120 days for bottleneck functions such as Head of QA and Qualified Person: what that means economically.
Candidates who would never have applied.
The ideal candidates in quality management, tech transfer and site leadership are visible in no applicant database, answer no job posting and do not respond to standardised LinkedIn requests. They are content in their current position, or at least not actively dissatisfied. That is the reality for most top profiles.
The value ANDRIS Consulting adds lies in activating these passive candidates. We approach them personally, at eye level, and make the specific constellation of a mandate so transparent that a conversation about moving becomes possible at all. We do not draw a requirements profile but a picture. We show the impact the person can have in this concrete situation, the room to shape things the environment offers, and whether this constellation is personally better for them than their current one. To do that, we listen first.
Direct approach at eye level is the method. Activating passive top performers is the result. Our clients receive a different candidate mix than they would through classic job postings or active sourcing.
A classic case in pharma headhunting is the confidential search. It is used when an incumbent has to be replaced and the search must not become public. In this case ANDRIS Consulting ensures the highest level of confidentiality, so the company can manage a smooth transition without creating unrest within its own team or toward the authorities.
Functions we fill.
ANDRIS Consulting’s mandates cover the entire CDMO space from different perspectives: pharma companies with their own production, external contract manufacturers, contract developers as well as suppliers, raw-material producers and packaging companies that supply CDMOs and pharma manufacturers.
ANDRIS Consulting fills Site Head, Plant Manager and site leadership roles for GMP and non-GMP production environments, sterile and non-sterile, solid forms, biologics and multi-purpose facilities. Director Operational Excellence and Head of Manufacturing with a Lean and Six Sigma background. Head of Engineering and Project Director for brownfield retrofits, new-site build-ups and modernisation projects.
ANDRIS Consulting fills Head of Quality Assurance, Chief Quality Officer and QA Director for GMP-regulated production environments. Qualified Person under § 14 AMG, permanent and interim. Head of Supplier Quality and External Quality for risk-based supplier qualification and audit programmes.
ANDRIS Consulting places tech transfer leads and Heads of MSAT as a bridge between sponsor, contract manufacturer and contract developer. Tech Transfer Managers and Process Development Managers for scale-up, method transfer and process validation for oral solid forms, biologics and sterile liquid dosage forms.
ANDRIS Consulting fills Business Development Managers and Key Account Managers at suppliers that supply CDMOs with raw materials, excipients, packaging or services. Business Development Managers on the CDMO side for acquiring and managing sponsor clients. Account Managers and Sales Managers with proven access to the CDMO market in DACH and Europe.
In the CDMO and GMP space, ANDRIS Consulting fills, among others, the following functions, permanent and interim, in Germany and the DACH region: