QA External Manufacturing

Our client, an internationally renowned pharmaceutical company is currently looking for a Quality Assurance (QA) External Manufacturing ideally from the area of biologics/vaccines available immediately for Lucerne area, to join an international team for a period of 12 months.

Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over. Hybrid work model (2 days Home-Office).

QA External Manufacturing (m/f/d)

Our client, an internationally renowned pharmaceutical company is currently looking for a Quality Assurance (QA) Specialist External Manufacturing ideally from the area of biologics/vaccines available immediately for Lucerne area, to join an international team for a period of 12 months.

Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over. Hybrid work model (2 days Home-Office).

Description

As a key liaison between internal teams and contract manufacturing organizations (CMOs), this role is ensuring full compliance with global GMP standards, company quality policies, and regulatory requirements. Partnering closely with external sites, the QA Specialist will be driving quality oversight, fostering continuous improvement, and safeguarding product integrity from manufacture to market.

The candidate will be responsible for performing the following tasks:

• Reviewing and approving master batch records, ensuring compliance with internal policies, procedures, and regulatory expectations.

• Leading investigations into routine and complex deviations, driving effective corrective and preventive actions.

• Supporting and approving process and analytical method changes, maintaining compliance and consistency.

• Managing retention samples, coordinating the shipment of materials and reagents - including under quarantine - to support product licensing and foreign registration.

• Overseeing process validation activities, reviewing and approving validation documentation and tech transfer reports.

• Preparing for pre-approval inspections (PAI) and supporting regulatory submissions and post-approval changes.

• Conducting regular site visits, building strong relationships with external manufacturers, and monitoring performance to enhance quality and reliability.

Profile

In order to be considered for the role, the selected candidate must have:

• Degree in Science, Engineering or any relevant technical discipline (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent)
• Experience in the pharmaceutical industry with strong knowledge of Quality Systems, Quality Assurance, and Quality Control, as well as global GMP and regulatory requirements
• Ideally experience working with CMOs for biologics/vaccines
• Solid knowledge of external manufacturing management, supply chain, and operations
• Fluency in English and German as initial master batch record reviews will be conducted in German
• Problem-solving mindset
• Ability to work independently with minimal guidance, while acting as a subject matter expert (SME) and potentially mentoring less experienced colleagues

Nice to have:

• Ability to lead projects or teams, promoting open communication, coaching peers, and aligning stakeholders on complex quality topics

• Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs)

• Direct experience with managing external partners

Job Offer

The selected candidate will be part of a international team and support the development and high quality of novel biopharmaceuticals.

Hybrid work model (2 days Home-Office).

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