We are hiring: Head of Quality & Process Operations

If you are a PRO with OIL, ISO, HACCP, GMP, QC, SOP, CMO, CoA, SDS, PDS and CAPA, and a START-UP (ÄIO!) is where you thrive, we want to hear from you! Does quality run in your veins? Do you naturally keep processes organised, standards high and every detail under control? And when the systems don’t exist yet, are you the person who enjoys building them?

ÄIO is looking for a Head of Quality & Process Operations to join our team in Tallinn!

We are entering an exciting new phase, moving from pilot-scale operations towards commercial manufacturing of our fermentation-derived fats and oils. This transition requires more than maintaining existing quality standards. We need someone who can establish practical, reliable systems, take ownership of product quality and work hands-on with production processes, equipment and manufacturing partners. This is a role for someone who enjoys both the technical details and the bigger picture, from incoming raw materials to the final product delivered to our customers.

The opportunity

As Head of Quality & Process Operations, you will take responsibility for quality management and downstream processing operations across ÄIO’s growing ingredient portfolio.

• You will help ensure the consistent quality of our three cosmetic ingredients, Encapsulated oil, Fermira™ RedOil and ZymaLipid, while developing the systems and procedures required for commercial-scale manufacturing.
• You will work closely with our Product Innovation, R&D, process development, supply chain and commercial teams, as well as external manufacturing partners and laboratories.
• Your mission is to establish a quality management framework that works in practice, supports production scale-up and ensures that every product leaving ÄIO meets defined specifications and customer expectations.

Your key responsibilities

1. Product quality, control and release

You will oversee product quality throughout the manufacturing and delivery process, from receiving dried fermentation biomass to extraction, refinement, quality release and shipment readiness. Your responsibilities will include:

• Establishing procedures for incoming material inspection, sampling, quarantine, acceptance and non-conformance.
• Reviewing batch documentation, verifying Certificates of Analysis (CoA) and making final product release or rejection decisions.
• Maintaining specifications and quality standards for Encapsulated oil, Fermira™ RedOil, ZymaLipid and future lipid ingredients.
• Ensuring that every released product has accurate, complete and customer-ready documentation, including CoA, SDS and PDS.
• Working with the Product Innovation team to continuously improve product specifications based on stability data, formulation performance, customer feedback and manufacturing experience.

2. Oil extraction and refinement operations

Quality is not just about documentation. It starts with understanding the production process. You will:

• Coordinate and oversee pilot-scale oil extraction and related refinement operations.
• Establish quality requirements for commercial-scale manufacturing.
• Develop and standardise analytical methods, in-process controls, critical parameters and acceptance criteria.
• Troubleshoot processing challenges and support continuous improvement.
• Maintain safe, orderly and audit-ready pilot operations, including equipment records, cleaning requirements and material reconciliation.

3. Building our quality management system

One of your most important responsibilities will be developing and implementing a practical quality management system aligned with ISO 22716 and other applicable requirements. This includes:

• Creating and maintaining Standard Operating Procedures (SOPs), work instructions, batch records and product specifications.
• Establishing document control, training records, change control, deviation management, CAPA, complaint handling and risk management processes.
• Ensuring full traceability from fermentation batches and incoming materials through processing, product release and customer shipment.
• Preparing for supplier, customer, certification and regulatory audits.
• Managing audit findings and implementing effective corrective actions.

We are looking for someone who understands that a successful quality system is not simply a collection of documents. It must be practical, reliable and integrated into everyday operations.

4. Analytical methods and product performance

You will ensure that our ingredients meet the required standards for identity, purity, stability, safety and performance. Your work will involve:

• Developing, qualifying, transferring and maintaining analytical methods.
• Coordinating internal testing and external laboratory services.
• Managing sampling, test requests, results, data integrity and reference samples.
• Monitoring product stability and quality trends to identify variations early.
• Interpreting analytical results and translating them into clear manufacturing, quality and customer decisions.
• Working with Product Innovation to define critical quality attributes, analytical methods and acceptance criteria.
• Evaluating quality risks, process variability, specification feasibility and manufacturability of new ingredients before scale-up.

5. Working with manufacturing partners and commercial teams

As ÄIO expands production, collaboration between internal teams and external partners becomes increasingly important. You will act as the primary quality and downstream-processing contact for manufacturing partners and relevant suppliers. Your responsibilities will include:

• Supporting technical transfers, supplier qualification, quality agreements and audits.
• Coordinating specifications, process controls, deviation handling and batch investigations.
• Communicating quality requirements to contract manufacturing organisations (CMOs), external processors and pilot plant personnel.
• Ensuring that product availability, release schedules, certificates, packaging and technical documentation support customer deliveries.
• Working closely with R&D, Product Innovation, logistics, supply chain and commercial colleagues to align production capabilities with customer commitments.

Who are we looking for?

We are looking for a pragmatic, technically confident quality leader who enjoys creating structure, solving problems and taking ownership.

Essential experience and capabilities

• Practical industrial experience in oils, fats, lipid ingredients, oleochemicals, food ingredients, cosmetic ingredients, biotechnology or a comparable regulated manufacturing environment.
• Hands-on experience with oil extraction and refining or closely related downstream processing operations.
• Experience developing, implementing or operating quality management systems.
• Strong understanding of controlled documentation, deviations, CAPA, change control, traceability, supplier quality and batch release.
• Ability to combine independent quality decision-making with cross-functional coordination.
• Experience working with CMOs, external laboratories, equipment suppliers or outsourced manufacturing partners.
• Strong technical writing, organisational and communication skills.
• Confidence in making clear, well-documented quality decisions.
• Fluency in English.

Preferred qualifications

We would particularly welcome candidates with:

• An MSc or PhD in chemical engineering, food technology, biotechnology, bioprocess engineering, pharmaceutical sciences, chemistry or a related field.
• Direct experience with ISO 22716, cosmetic Good Manufacturing Practices (GMP), food safety and quality standards, HACCP, process validation, facility start-up or audit leadership.
• Experience developing or validating analytical methods for oils and lipids, including moisture, carotenoids, colour, oxidation, fatty-acid profiles, contaminants and stability.

What will success look like?

Your contribution will be central to ÄIO’s transition into commercial manufacturing.

Success in this role means:

• Incoming materials, in-process products and finished batches move through a clearly defined, traceable and controlled quality system.
• Fermira and ZymaLipid products are released against approved specifications with complete, reliable, customer-ready documentation.
• ÄIO has a fully implemented, practical and usable ISO 22716-aligned quality management system.
• Our planned 2027 extraction facility begins operations with established analytical methods, quality controls, trained personnel and clear operating procedures.
• Our commercial team receives accurate information on product status, release timing, certificates and documentation.
• Product Innovation, pilot production and external manufacturing partners work according to aligned quality requirements, specifications and analytical methods.

A builder’s mindset is essential

This is not a role for someone who wants to maintain an established system from behind a desk. We are looking for someone equally comfortable on the pilot plant floor, reviewing batch documentation, solving a technical challenge with a manufacturing partner or discussing product quality with a customer. You should enjoy creating systems where none exist, introducing structure into fast-moving operations and making sure quality is built into every step of production.

If OIL, ISO, HACCP, GMP, QC, SOP, CMO, CoA, SDS, PDS and CAPA are more than just acronyms to you, and START-UP is where you thrive, we want to hear from you!

Especially if you are passionate about building systems from scratch, setting high standards and turning ambitious plans into reality at sprint speed.

Join ÄIO

ÄIO is an Estonian biotechnology company developing sustainable fats and oils through fermentation. Our technology transforms organic side streams into functional lipid ingredients, offering alternatives to conventional oils used in cosmetics and other industries. As we scale our production and bring more fermentation-derived ingredients to the market, quality and operational excellence are essential to our growth. This is an opportunity to take real ownership, work across scientific and industrial disciplines and help build the quality infrastructure of a growing biotechnology company.

Ready to build the next chapter of ÄIO with us?

Get in touch to learn more about the Head of Quality & Process Operations position, write your motivation email and send your CV to nemailla.bonturi@aio.bio.

Location: Tallinn, Estonia
Employment: Full-time
Fluent: Estonian and English