Head Of Frontline Qa

The Opportunity

The role is accountable for developing and leading the Front Line Quality Assurance function for a CSL Seqirus Manufacturing facility to ensure pharmaceutical quality for all products manufactured, tested, distributed and/or released. Responsible to ensure that all products, utilities, services, and operations for the manufacturing site are in compliance with relevant quality, regulatory and company specific requirements and guidelines.

The Role

• Represents Quality as the primary subject matter expert during regulatory inspections, internal audits, and customer audits. May serve as the host for inspections as needed. ]
• Ensures effective professional development of direct and indirect reports, through combination of coaching, mentoring and development planning; direct personnel management of QA Management (Sr. Mgr, Mgr, Supervisors, Associates, Specialists), and indirect management of their direct reports.
• Providing QA support for projects and activities relating to all GMP operations on site.
• Participating in self-inspections for all areas and drive resolution to audit findings
• Serves as the primary quality partner to the Director of QC, Director of FF, Director of Bulk and drives strategy and direction as the single quality point of contact in each respective leadership forum (i.e. BOLT/SOLT/QCOLT)
• Providing 24/7 QA coverage across the entire facility.
• Assessing criticality of deviations and change controls; driving appropriate batch impact, corrective actions, implementation actions, and batch control activities
• Manages a team responsible for: Quality oversight for all GMP areas of a facility, including QC, Manufacturing, Facilities, Warehouse, Pilot Plants, and Engineering; Reviewing batch specific documentation and data to assure compliance with the license, requirements of the CSL Seqirus Quality system and all relevant cGMP regulatory requirements in real time.
• Actively maintaining and promoting a cGMP compliant culture, ensuring that the highest standards of quality, housekeeping, and safety are applied within all GMP areas across the site, through QA walk-throughs and presence on the operations floor.
• Leading both change and deviation review boards or appropriate forum as dictated by local requirements
• Directly responsible for implementation and use of Quality Systems for GMP areas in the facility, such as DR/CAPA management, Change Management, document management and training systems, etc:
• Supporting the development and implementation of SOPs, batch records, and supplemental documents ensuring that the most current process and standards are being performed.
• Oversight of BPDRs and notification to regulatory authorities as required
• Ensuring compliance in accordance with CSL Seqirus’ quality, compliance, safety, GMP and regulatory standards at all times
• Utilizes knowledge of evolving regulatory requirements and trends to identify and implement changes to assure the facility stays in compliance Focuses energy on achieving bottom-line results by establishing challenging goals on individual and team projects Utilizes key performance metrics to influence the design, implementation, and refinement of team or project activities, incorporating key learnings and past experiences Encourages the team to achieve results in the face of uncertainty of success or challenging set-backs, fostering employee motivation and commitment
• Insuring compliance with use of Quality Systems
• Sets department policy regarding staffing, hours, and job function to deliver on planned projects and production goals.

Your Skills And Experience

• Experience with regulatory authorities and inspections required
• Advanced knowledge of appropriate regulatory requirements including GMP/GQP
• Bachelor’s degree in related scientific field or equivalent
• 10+ years’ relevant experience within the biopharmaceutical industry
• 3+ years of demonstrated leadership & management of subject matter experts required
• Knowledge and experience in biotechnology processes, sterile product manufacturing, laboratory, warehouse, and maintenance/utilities operations required.
• As applicable to the region, QP (Qualified Person) or RRP (Release Responsible Person) experience may be required.
• Knowledge of Quality Systems required

About Us

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.

About 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.

We want Seqirus to reflect the world around us

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

Do work that matters at Seqirus!