Global QC Manager, Capital Equipment and Raw Material Management

Job Purpose:

The Global QC Manager will be a member of the Global Analytical Services team within QC and will be responsible for the QC Asset Management Program (AMP) and oversight of a standardized raw material testing and release approach across the QC network. Pertaining to the AMP, the position will be responsible for the life cycle management of QC Capital Equipment and collaborate with impacted stakeholders to prioritize projects within the CSL 10-year CAPEX Plan. For raw material management, the position will develop standardized specifications and provide oversight to external raw material testing, ensuring all work adheres to cGMP and regulatory regulations. This role requires excellent planning and organizational skills for managing complex processes and flexibility to navigate or overcome unanticipated obstacles. This role reports into the Head of Global Analytical Services and works cross-functionally with stakeholders in QC, AS&T, MS&T, Regulatory, and Engineering.

Duties and Responsibilities

• Conduct periodic asset condition re-evaluations in partnership with equipment owners and update the 10-year CAPEX Plan accordingly in support of annual fiscal year budget planning
• Prepare and submit cost estimates for the prioritized replace recapitalization projects to enable risk based, data driven investment decisions in partnership with impacted stakeholders
• Present proposed QC CAPEX projects for endorsement at the Quality Capital Approval Group (QCAG) for prioritization and approval of spend
• Develop standardized raw material specification template and own/manage global raw material specifications to ensure alignment across operational sites
• Own and implement all technical changes associated with raw material specifications
• Partner with procurement to optimize sourcing strategies, specifically as it pertains to optimized lot sizes, material containers, lot sharing between sites, full specification testing approach, supplier qualification, etc.
• Together with the local QC teams, ensure the establishment and reliable operation of external raw material testing
• Act as the technical key partner and SME for external supplier integration to evaluate, establish, and maintain external testing labs.
• Support operational excellence initiatives through technical and analytical innovation.

Qualifications:

• Degree in related scientific discipline (natural, pharmaceutical, medical, archival or information technology) with 5+ years of laboratory experience in a GMP regulated Biologics or Pharmaceutical environment
• In depth knowledge of laboratory instrumentation gained through hands-on training and experience across multiple scientific disciplines preferred.
• Understanding and application of basic project management tools and applications, i.e. MS Project, excel, etc.
• Able to prioritize tasks and manage multiple projects yet understand when to escalate issues
• Ability to handle multiple projects in a fast-paced and high-volume dynamic environment
• Work collaboratively with other functions
• Strong problem-solving skills with demonstrated attention to detail
• Knowledge of GMPs, safety regulations and data integrity. GMP experience in a pharma/biotech environment
• 5 to 10% - Occasional international travel will be required across the manufacturing sites.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.