(Senior) Quality Assurance Officer

The role

Most QA roles sit inside a factory. This one sits between the company and its factories. The employer holds the marketing authorisations and the responsibility for product quality, but manufacturing is done by contract manufacturers in the Netherlands and abroad. Your job is to make sure that what those suppliers do, and what they change, stays within the company's quality system and the GMP and GDP requirements it operates under.

In practice that means owning the supplier side of the quality system: assessing change notifications from contract manufacturers and suppliers and working out what they mean for the company's own products and documentation; raising and coordinating the change controls that follow, so that changes land in time and are properly closed; compiling Product Quality Review reports, drawing on suppliers' PQRs and quality data; keeping supplier performance and risk visible and under control; supporting supplier qualifications and audits; and writing and maintaining the SOPs and work instructions that hold it all together. You work alongside Regulatory Affairs, Supply Chain, the Qualified Persons and the Responsible Person day to day.

The environment

An independent pharmaceutical company in Noord-Holland, established for well over a decade and growing, with a quality department of roughly a dozen people and a QA team of a handful of officers reporting to the QA Manager. The company has moved from a purely commercial operation towards a full quality organisation, and QA is treated as the foundation of that rather than as paperwork. Processes are still being built and improved, which means your judgement shapes how things are done, and also that you need to be comfortable when the procedure does not yet exist.

The culture is direct and informal, with short lines to management. The team is stable and, by its own account, enjoys working together.

What we look for

• Five or more years in a QA role in a GMP or GDP regulated environment, with demonstrable understanding of pharmaceutical production processes.
• Hands-on with the core quality documentation: deviations, change controls, CAPA, SOPs, and ideally Product Quality Reviews.
• Experience with third-party manufacturing or contract-manufacturer oversight is what makes a candidate senior here; it is preferred, not required.
• Working knowledge of GMP and GDP legislation and guidance as it applies to a marketing authorisation holder and distributor.
• Analytical, precise, and able to tell the important from the urgent. Comfortable pushing back on a supplier and explaining the outcome to a colleague in Supply Chain who needs the stock.
• Fluent Dutch and English, spoken and written. Dutch is essential here: supplier correspondence, contact with the inspectorate and daily work in the office all run in Dutch.
• HBO or WO level, in pharmacy, life sciences or a related field.

The "Senior" in the title is earned by the CMO-management and PQR experience. Strong candidates with five years of solid GMP QA and less supplier exposure are welcome at the Officer level.

Practical

Permanent, full-time, on site in Noord-Holland. The package includes a salary band that scales with experience, travel allowance, pension contribution, a generous holiday entitlement with the option to buy more, and an annual personal development budget; the figures are shared in the first conversation. The role is fully on site, so it suits people who live within comfortable reach of the Amsterdam region.

Apply through Axeleon with a CV or LinkedIn link. Russell reads every application himself and gets in touch if your profile fits, and nothing goes to the employer without your say-so.