What are the responsibilities and job description for the Associate Director, Product Development and Research Quality position at CSL Seqirus?
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 :
People Management
Your skills and experience
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 whats 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.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
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