Associate Director Safety Systems Program Lead; Global Safety and Pharmacovigilance

1 month ago

Berkshire, United Kingdom CSL Seqirus Full time
The Associate Director, PV Systems Project Manager establishes, executes, and upholds a comprehensive project management framework to propel priority Global Safety and Pharmacovigilance (GSPV) business endeavors related to PV technology and safety systems innovations and/or PV process improvements.
This role will lead cross-functional teams, collaborate with technical experts, and manage complex projects that deliver inventive solutions within approved budget, scope, and timelines to optimize PV systems and/or operations to gain efficiencies, improve quality, and/ or ensure continued compliance.
The role provides strategic inputs for business planning in alignment with R&D objectives.
With strong R&D business acumen and IT Project Management experience, the Associate Director, PV Systems Project Manager understands the pharmaceutical software lifecycle and directs cross-functional efforts to implement and advance innovative technological solutions.
Responsibilities include:
- Provide input into GSPV's long range technical roadmap considering the current system landscape and strategic objectives for Pharmacovigilance including research on emerging trends and technologies to further optimize internal capabilities.
Lead, influence, and mobilize transversal teams of subject matter experts, to foster collaboration, gain alignment on 'to be' process/ data maps and drive shared accountability towards common goals.
Lead project planning, execution and oversee all aspects of the future solution to meet business goals.
Lead project business case development, facilitate decision support, and shepherd project(s) through concept and approval phases, including finance approval.
Utilize well established and novel project management methodologies and best practices to drive efficient and effective project execution, ensuring quality, consistency, and adherence to project requirements.
Document and maintain comprehensive project plans that include detailed scope, timelines, resource allocation and budget plans.
Track actuals to ensure the timely, successful execution of priority projects and initiatives.
Monitors project progress, identify risks and issues, and implement mitigation strategies to keep initiatives on track and deliverables on schedule Stays abreast of emerging PV technologies, industry trends and best practices.
Interface with external vendors to ensure adherence to CSL values and policies while delivering quality results.
Educations, Skills and Competencies:
- Bachelor of Science in Engineering, IS/Computer Science, or Data Analytics Degree (BSc/MSc/Diploma), Quality or Operations Management, Management Information Systems, or Business Analytics or equivalent is essential.
Certified Project Manager, PMP, PRINCE2 or Agile certifications a plus.
7-10 years in the biotech or pharmaceutical industry, including biomedical research organizations.
Minimum of 7 years of IT Project Management experience with extensive knowledge in drug research, development, and manufacturing (CMC, non-clinical, clinical, regulatory); PV experience is preferred.
Proven track record as a project manager leading cross-functional teams in a global, matrixed environment, handling complex technical and regulatory challenges.
Experienced in using standard project management tools, templates, and techniques such as critical path, milestone reporting, regular status reporting, variance analysis.
Advanced understanding of medical, safety, and regulatory functions, with a focus on Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP).
Proficient in IT Software Life Cycle processes, computer validation, and Quality Management Systems (QMS).
Experienced in process design, SOP development, and training material creation.
Familiar with GAMP5, 21 CFR Part 11, and other relevant industry regulations.
Knowledgeable in international standards and regulatory requirements.
Strong grasp of legal/regulatory compliance and quality management principles.
Excellent attention to detail and ability to collaborate effectively in global, cross-functional teams.
Proficient communication skills in English (verbal and written).
Our Benefits CSL 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 CSL Seqirus.
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 Seqirus to reflect the world around us As a global organisation 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 Watch our 'On the Front Line' video to learn more about CSL Seqirus

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