QA Project Manager (w/m/d)

QA Project Manager (w/m/d)

Location: Visp, Switzerland

Duration: 01/06/2025 to 31/12/2025 + possibility of an extension

Key Responsibilities

• Support continuous improvement programs to establish an effective Quality Management System.
• Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
• Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs.
• Author, review and approve GMP-relevant documents and SOPs.
• Responsible to present Drug Product QA topics during the conduction of all customer audits and regulatory inspections within DP.
• Participate in internal audits as required by the organization.
• QMS: Organize and manage monthly Quality Council & Risk Register
• KPI reporting Tracking of key Quality indicator on a monthly basis in QA staff meeting
• Monthly update of FLYING CARPET of Quality related KPIs.
• Gap Assessment for HA/Audit obs at other MODULES and clients facilities
• Tracking and follow-up on daily update of HOSHIN Tier 1 and Tier 2
• Back-up of Head of QA DPS in daily HOSHIN 2
• Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations.
• Support and approve project / product specific risk assessments.
• Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
• Review and approve executive batch records, prepare batch release for the responsible person (FvP), including recommendation on disposition status.
• Customer contact in regards to QA topics. Support and manage interactions in cases of changes, deviations, technical complaints, out of specification results and other
• Delegate of FvP for Batch Disposition of DP.
• Delegate of the FvP for conditional release according to CHVI-4553 and CHVI-265873

Key Requirements

• Bachelor's or advanced degree in Biotechnology, Chemistry, Pharmacy, or a related field.
• Several years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of GMP and other relevant regulatory requirements.
• Proven experience in drug product processes and quality management systems.
• Strong communication and presentation skills for representing QA in cross-functional teams and during audits.
• Excellent customer service orientation and problem-solving skills.
• Strong organizational and project management skills.
• Meticulous attention to detail for reviewing and releasing product-specific documentation and batch records.
• Ability to perform gap assessments and effectiveness checks.
• Familiarity with conditional release protocols (e.g., CHVI-4553 and CHVI-265873).

In Switzerland, for contract roles it is mandatory for the candidate to be a Swiss citizen or a European passport holder.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.