Part-time External Quality Manager

Continuous improvement and Quality

In regulated environments such as the pharmaceutical industry and its suppliers, having a Quality Manager is an essential requirement to guarantee regulatory compliance, document traceability, product safety and customer trust.

We know that, in many cases, especially in small and medium-sized companies, early-stage projects or plants in expansion, it is not always feasible to incorporate a full-time senior profile.

Therefore, we offer a flexible and tailored service, acting as your part-time external Quality Manager, designed to meet this need in an effective, professional and cost-effective way.

In addition, once the department is functioning properly, we can help you find, train, and transition to an in-house Quality manager.

What do we offer as an external Quality Manager?

We assume the functions of the Quality Manager in a partial and personalized way, with a practical, technical approach and aligned with the standards applicable to your industry (ISO, GMP, etc.). Some of the tasks we can perform:

  • Implementation of Quality standards (ISO, GxP, etc.).
  • Review, update and improvement of your Quality system and its documentation.
  • Direct support in internal and external audits
  • Support in the Management of non-conformities, CAPAs and deviations.
  • Monitoring of quality indicators and continuous improvement.
  • Support in technical dialogue with customers, suppliers and authorities.
  • Trainings of staff on key quality and compliance issues

In addition, our team combines quality expertise with strong production and operations know-how, allowing us to provide a holistic view of the process and facilitate coordination across departments.

Advantages of hiring a part-time external Quality Manager

  • Flexibility: we adapt the dedication according to your real needs.
  • Cost savings: avoid hiring a full-time Quality and Senior Technician profile.
  • High specialisation: we have extensive experience in regulated environments and GMP processes.
  • Cross-cutting vision: integration of quality, production and operations.
  • Peace of mind: We make sure you comply with regulatory requirements.

When can this service be useful to you?

  • For small and medium-sized companies and growing startups that do not yet have a quality internal structure.
  • To temporarily cover a staff leave, absence, or transition.
  • In imminent audits where technical reinforcement is required.
  • As part of a start-up project of new plant or production line.

Need to fill quality roles without hiring full-time?

Let’s help you implement or strengthen your quality system with efficiency, compliance and technical criteria.
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Frequently Asked Questions (FAQ)

What type of companies can benefit from this service?
Suppliers or companies in the pharmaceutical, cosmetic, veterinary or biotechnology sectors that operate under GMP regulations, and that need to comply with quality requirements without having to hire a full-time manager. It is also ideal for new projects, small installations or small and medium-sized companies.
What level of involvement can the part-time external Quality Manager have?
We adapt to your needs. We can offer from one-off support (a few hours a month) to more intensive dedication during audits, validations or critical phases of the project. The degree of involvement is defined flexibly and adjusted to your actual workload.
Can the external Quality Manager sign official documentation or be a representative before the authorities?
Yes. As long as it is formalized within the framework of our functions, we can assume technical responsibility for inspections and audits, sign GMP documentation and act as interlocutors with customers or regulatory agencies, complying with legal and confidentiality requirements. We can sign a contract with Quality nuances with the client.
Can this service be integrated with others such as drafting SOPs or staff training?
Absolutely. In fact, it is common for our clients to combine this service with the drafting of Standard Operating Procedures (SOPs/SOPs), training in good practices, or preparation for regulatory audits, generating a comprehensive quality support package.
How does the collaboration as an external Quality Manager begin?
We first hold a meeting or diagnosis to learn about the current state of the quality system and the specific needs of the company. From there, we propose a work plan with defined tasks, times and objectives. Collaboration can start immediately if required.