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Quality
Manager.

Part-time Fully remote English-language role Start Q3 2026

Our QMS is in place and ISO 9001:2015 certification is the immediate objective. The groundwork is largely done. What we need is someone to own the operational quality work — and grow into the Quality Management Officer function as the system matures.

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About Oncosia

The company.

Oncosia Scientific GmbH is a specialist dosimetry service company working at the intersection of nuclear medicine, medical physics, and regulated clinical research. We deliver dosimetry solutions to a range of clients: nuclear medicine departments in clinical centres, pharmaceutical industry sponsors, contract research organisations (CROs), and academic research partners.

Our work spans pre-clinical and clinical routine dosimetry, radiopharmaceutical trial support across Phase I–III, and regulatory submissions to FDA and EMA standards. Our quality process require strict compliance and audit-ready documentation.

We are a small, precise team. The Quality Manager owns the scope directly, works independently, and coordinates with the CEO and experts from the operational teams.

The role

What this is.

Our QMS is in place and ISO 9001:2015 certification is the immediate objective — the groundwork is largely done. You will work closely with the CEO from day one, taking ownership of the operational quality work: driving the CAPA process, maintaining accurate documentation, and keeping the system audit-ready through to initial certification and beyond. As your familiarity with our processes deepens, there is a clear path to the Quality Management Officer (QMO) function.

The role is designed for professionals who bring genuine expertise but are looking for a focused part-time commitment rather than full-time hours — whether re-entering the industry after a break or simply wanting substantive work without an all-or-nothing contract.

The scope is specific: you are not rebuilding the QMS or managing a team. The system exists; your job is to run it well. Quality in a regulated clinical context is not passive maintenance — it requires independent judgment, precise documentation, and the readiness to flag a problem clearly when one arises.

Responsibilities

What you will do.

CAPA & Nonconformity Management

  • Log, track, and follow up on nonconformities and CAPA items within the QMS.
  • Support root cause analysis and document corrective actions to ISO 9001 standards.
  • Monitor open CAPAs; escalate overdue items promptly.

Documentation Control

  • Review and maintain SOPs, work instructions, forms, and process descriptions for accuracy, version status, and compliance.
  • Manage document lifecycle in our GitHub-based QMS: updates, review cycles, and approval tracking.
  • Identify gaps between documented procedures and actual practice; resolve with the relevant team member.

Audit Preparation & Support

  • Prepare documentation packages for internal, customer (sponsor), and third-party surveillance audits.
  • Coordinate audit scheduling, logistics, and post-audit follow-up actions.
  • Support the CEO during external audits. As the role matures, take on independent audit facilitation.

Training Administration

  • Schedule and track internal quality training: GCP awareness, SOP onboarding, role-specific instructions.
  • Maintain training records in audit-ready format at all times.
  • Identify training gaps and flag updates needed to the training programme.
Management review support — Prepare quality KPI reports for regular management review meetings. Collate input from across the team and present it clearly and concisely.
Requirements

What we are looking for.

Background & experience

  • Degree in quality management, natural sciences, engineering, pharmacy, or a related field.
  • At least 2 years of practical QM experience in a regulated environment — life science, CRO, medical device, or clinical research.
  • Hands-on experience working within an ISO 9001:2015-compliant QMS. This means implementation, not just awareness.
  • Familiarity with CAPA processes and internal audit participation. Audit leadership experience is a plus.
  • Formal ISO 9001:2015 training or auditor qualification is preferred.
  • Familiarity with GDPR as it applies to clinical and research data handling.

Languages

  • English — fluent, written and spoken.
  • German — fluent, written and spoken.
  • Turkish — advantageous given our operations in Türkiye.

Skills & tools

Quality standards
ISO 9001:2015 — working knowledge in practice. You understand what implementation actually involves.
Regulatory context
familiarity with GCP · 21 CFR Part 11 · 21 CFR Part 820 · FDA Guidance for Industry
Data protection
familiarity with GDPR and HIPAA as applied to clinical and research data: data subject rights, processing records, and documentation obligations in a regulated context.
Risk management
ISO 14971 familiarity expected — risk management for medical devices and related services; ability to support risk assessments and maintain risk documentation within the QMS.
Change control
Experience managing controlled change processes within a QMS — raising, assessing, and closing change requests in line with documented procedures.
Document control
GitHub — used for version control and document management. No coding required; comfort navigating the platform is.
Documentation tools
Markdown (our QMS documentation is in Markdown) · Microsoft 365. Precise, structured written English is essential.
Apply

How to apply.

We do not need a lengthy cover letter. Tell us briefly:

  • → Where you have worked within a QMS — specifically.
  • → What your relationship with ISO 9001 has been in practice.
  • → Why a part-time role in this context appeals to you.

A focused, honest application matters more than a comprehensive one.

Quality Manager

Part-time Remote English
Start date Q3 2026
Location Fully remote
Apply — mail@oncosia.de

Subject line: Application — Quality Manager