Quality Assurance Manager

cts for Seqirus Netherlands B.V., completes final product release checks and recommends disposition of the finished product to the EU Qualified Person.

• Generates Lot Release Protocols and Marketing Information Forms and tracks national competent laboratory submissions for batch release.

• Delegates for the EU Qualified Person in meetings and for pre-defined activities

• Supports new product introduction and implementation of the global projects and changes at Amsterdam site.

• Prepares, submits and tracks national competent laboratory submissions for batch release.

• Supports data collation for the Qualified Person relating to IMP release

Quality Assurance - QC support

• Performs monthly checks on the QC facilities and data integrity.

• Reviews and approves validation protocols and reports and oversees validation activities.

• Attends weekly compliance meeting and regular tiered accountability meetings with QC.

• Supports annual retain inspection and inspection of retains for complaints/deviations.

• Reviews and approves procedures, deviations (Level 1 and 2), OOS / OOT, root cause investigations, change controls and CAPAs for the QC laboratory.

QMS related activities

• Actively involved in the site quality systems, risk assessments, and self-inspections.

• Updates and Approves quality documentation relating to Seqirus Netherlands B.V.

• Owns, Reviews and approves procedures, deviations (Level 1 and 2), Product Technical Complaints (minor and major) root cause investigations, change controls and CAPAs related to Seqirus Netherlands B.V.

• Promotes a cGMP compliant culture, ensuring the highest standards are applied on the site, observing current regulations and procedures.

• Participates/supports in inspections, audits and self-inspections, recalls and mock-recalls.

• Supports implementation of commitments.

• Coordinates PQR activities and generates and approves PQR reports.

• Generates LQMR packs and presents data as required and generates monthly compliance KPI data

• Attends CoP meetings on behalf of Seqirus Netherlands B.V.

Education Requirements

Minimum: Bachelors degree (BSc) in sciences

Preferred: Eligible to meet the education requirements to be an EU QP

Experience Requirements

Minimum of 2 years of GMP industry experience; vaccines, steriles and biological experience is preferable

Experience of managing Quality Assurance procedures preferred

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://https://www.csl.com/accessibility-statement.

Watch our 'On the Front Line' video to learn more about CSL Seqirus