PAREXEL Informatics is one of the industry’s leading solution providers and we help customers accelerate the drug development process through innovation. Our product portfolio is built on leading-edge technology and is combined with extensive medical and clinical expertise. As the technology business unit of PAREXEL International Corporation, we're able to leverage our massive investment in technology with our parent company's wealth of hands-on clinical expertise.
This role is based in our new modern state of the art office in Nottingham city centre which has excellent transport links and has a great working environment that has the feel of an innovate technology company.
As the Associate Director, Technology Quality Management you will direct efforts to define, adopt and oversee compliance to processes and standards as the fundamental baseline for technology development, validation and delivery across PAREXEL. Directs efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units.
- Custodian and leader of the PAREXEL Quality System. Acts and is recognized as an ambassador for quality across the business and with customers.
- Leads or supports development, implementation and management of PAREXEL strategic objectives..
- Representation and leadership at Quality Review Boards, Quality Forums and other meetings that govern, maintain and improve the Technology Quality Management Oversight System
- As team leader, responsible for providing direction, mentoring and developmental plans to ensure teams meet or exceed business and personal goals in keeping with PAREXEL’s high performance culture.
- Ensures the timely completion of Performance Management and Development (PMD) tasks with direct reports.
Standards & Framework
- As continuous process enhancement leader, collaborates with functional leads to design, re-engineer, implement and adopt the technology quality framework used across PAREXEL for the development, validation and release of products and software solutions.
- As a leader for training and adoption, responsible for the development, implementation and continuous improvement of the training and adoption program focused on infrastructure, software and system development lifecycles and related change control and problem management processes.
- Guides and supports Validation Leads to provide guidance, consultation and overall expertise to project teams in support of validation activities through the applicable lifecycle.
- Provides input and consultation to Validation Leads responsible for overseeing, monitoring compliance status and activities to ensure validation state for a project, business area or portfolio.
Technology Project Quality Evaluation
- For technology-related Quality Issues (QIs), provide QI management support to internal customers, with particular emphasis on appropriate description of the issue, accurate classification, oversight of root cause analysis and consultation on appropriateness of corrective and preventive actions.
- Hosts technology related Sponsor audits.
- As GxP Regulatory SME, provides expertise to technology portfolios to facilitate interactions with business, technology, quality management teams and clients.
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 10+ years clinical research experience.
- Postgraduate degree in a science, technology or industry-related discipline preferred.
- Industry recognized qualification i.e., project management, Lean Six-Sigma, auditing and/or risk management.
- Subject Matter Expert (SME) in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing.
- Advanced knowledge of continuous improvement methodologies.
- Exhibits competency across core project management activities including a strong focus on key performance indicators.
- Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.
- Ability to work in an customer-focused, fast-paced and rapidly changing environment with the ability to prioritize workload and manage multiple and varied tasks with enthusiasm.
- Highly motivated, seeks opportunities for development, client-focused, and has the ability to work unsupervised and on own initiative, which includes making appropriate decisions in ambiguous situations.
- Exhibits a sense of urgency when addressing problems in keeping with PAREXEL’s High Performance Culture.
- Culturally aware and ability to think and work globally; ability to lead a 'virtual’ and global team, which may include travel across PAREXEL facilities worldwide.
- Intermediate desktop software skills (MS Office, Excel, Visio, Adobe PDF etc.).
Knowledge and Experience:
- Clinical trials and /or research work experience a must, with emphasis on GCP and technology compliance.
- Expert in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.
- Continuous Improvement
- Process Improvement
- Quality Management
- Six Sigma
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