QA Manager (m/w/d)

TRD Global Clinical Supply manages the packaging, labeling and worldwide distribution of clinical finished goods.
We are looking for a QA Manager on a temporary basis and ensure that all GCS activities meet cGMP standards. You will provide quality oversight for clinical supply activities and contribute to the timely delivery of materials for global trials.

Tasks :

• Batch release of clinical supplies (packaged and labeled finished goods, materials, and components), including review and approval of GMP documentation and issuance of batch certificates.
• Deviation, and incident management: evaluation, QA oversight, support to investigations, and approval of records.
• Change control management for GCS processes and documentation.
• Write, review, and approve GMP-relevant documents (SOPs, CoAs, risk assessments, checklists, packaging & labeling documentation).
• Support audits and inspections for TRD GCS topics.
• Provide QA support for GCS operations and ensure alignment with TRD QA standards.

Qualification:

• Master’s degree in life sciences or equivalent education.
• 3–5 years of Pharma QA experience, ideally in development, manufacturing, packaging, or clinical supply.
• Strong knowledge of cGMP and QA processes (batch release, deviations, changes).
• Hands-on experience with SAP (materials management, batch records, release workflows).
• Experience with 1QEM is a strong asset.
• Excellent communication and decision‑making skills.
• Fluent German and English (oral & written).
• Nice to have:
• Experience in packaging and labeling operations or in global clinical supply chains.
• Experience collaborating with CMOs or external partners.

Requirements:

Capacity : 5 days per week (100% on-site)

Location : Basel, Switzerland