The Opportunity

Reporting to the Sr. Director of Product Development Quality, you will be responsible for cross-functional collaborations with Product Development and Research Quality (PDRQ). The successful candidate is expected to implement full control over the phase-appropriate compliance state of the Waltham site, ultimately supporting and expediting the release of Clinical Trial Material (CTM) to clinical subjects and commercial launches.

The Role

Core Responsibilities:

• Site lead for all Waltham, MA Quality related responsibilities, leading and coordinating Quality Assurance activities to ensure compliance with company standards (SOPs), internal specifications, GxP requirements, and regulatory guidelines. Ensures effective and communications to authorities (Swiss medic, EMA FDA, etc.), supporting timely product release.
• Develop and implement strategic goals in alignment with functional leadership priorities.
• Directs appropriate resourcing model and budget management within PDRQ by strategic assessment of workload, required planning for staffing, coordination of consultant activities as needed, and ongoing review of forecasted expenditures.
• Coordinates and oversees deviations, CAPA, change controls, and PTCs, document/training to ensure a site in a compliant state with all applicable CSL internal policies and procedures.
• Works with GxP Quality (GCLP and QMS) counterparts or subordinates to implement phase appropriate Quality infrastructure at site.
• Ensures outsourced activities and ancillary supplier procurement comply with CSL and relevant Health Authority requirements. Ensures Quality Agreements are in place for key vendors in accordance with CSL policies.
• Responsible for planning Self Inspections and Internal Audits for the site. Assists with 3rd Party Quality audits as required to support Genetic Medicines development. Analyses audit observations, revie and approve reports, and proposes remedial actions to support continuous process improvement.
• Oversees studies that are performed to support commercial products and technology transfers.
• Provides technical guidance and recommendations to improve quality systems and processes.
• Manages the development and implementation of SOPs, ensuring updates are made as required by regulatory and compliance offices (both governmental and internal) to address significant deviations.
• Provides oversight to equipment commissioning, decommissioning, and qualification activities; and assay fit-for-purpose, verification, qualification, and the technology transfer activities.

Site Operations / Quality Support:

• Serve as a primary representative for R&D Quality in site quality management forums and discussions, including Global R&D Expert Team Meetings
• Chair and Manage GxP Quality Management Review meetings for Global Product Development for Genetic Medicine Product Development
• Serves as the primary R&D Quality point of contact for the genetic medicine governance meetings, serving as the Quality Assurance liaison between Business Process Development, Research, and the corresponding commercial sites.

People Management

• Manage a team of 3-4 FTEs directly or indirectly.
• Provide guidance and leadership to team of direct reports, including coaching, developing and one to one meeting to stay abreast of progress, projects, and other activities.
• Act as a resource for colleagues to ensure clear understanding, knowledge sharing, and mentorship.

Your skills and experience

• Bachelor's degree in pharmacy, Chemistry, Biology, or Biochemistry; advanced degree preferred
• 10+ years' experience in quality in the biopharmaceutical industry with 1 – 3+ years' leadership plus team management experience. Experience in commercial or clinical manufacturing is advantageous, including knowledge of phase appropriate quality systems.
• Sound knowledge of GxP, FDA, and EMA regulations
• Sound knowledge of pharmacopeias such as USP, EP, and other country-specific requirements
• Experience in the application of Quality Systems
• Previous experience managing a team of direct reports

Our Benefits

CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: 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. Learn more about CSL Seqirus.

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