Job Description

Senior Project Manager
Location: Basingstoke (Remote)
Pay Rate: 40 per hour
Shifts: Office hours, flexible

Increased innovation, along with substantial growth in the Specialty Diagnostics Group, has resulted in a need for a senior project manager with focus on business transformation and change control. The individual in this role will be a leader in ensuring that the project management teams achieve goals and objectives set by Group leadership. In addition, he/she will be responsible for identifying and mitigating risks, helping guide and mentor staff in project leadership, and communicating as needed on any issues and challenges that constitute obstacles to success. The Senior Project Manager will also make substantial contributions to setting strategic direction for business transformation and will be expected to partner with all functions in ensuring that the organisation achieves its goals. Performance of this individual's responsibilities will require good knowledge of regulatory requirements and quality systems required for in vitro diagnostic (IVD) products

Responsibilities:
The duties and responsibilities include, but are not limited to the following:

• • The manager of project management, will be responsible for managing complex projects cross division and group level with duties and responsibilities as follows: o Developing project tasks, deliverable, dependencies and resource requirements

• • Creating, maintaining and organising necessary documentation and records; responsible for the quality of project deliverables and documentation
  • Facilitates the completion of various validation deliverables, such as product risk analyses, master validation master plan, related activities & documentation.
  • Oversees and prepares project team budget including resources and costs collaborating with finance and other cross-functional departments.
  • Identifying, documenting and communicating project risks and contingency plans.
  • Tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information.
  • Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.
  • Exercising scope management with consideration for the customer, team, and company needs
  • Promoting a proactive, professional culture and contributing to the group's success.

Significant contribution to the development of strategy for the organisation and the implementation of strategy by project teams in Product Life Cycle.
Leadership in the development of processes and tools for value streams including Change Management and business transformation project funnel capture and management and prioritisation.
Conduct lessons learned sessions to identify areas for improvement and maintain tracker for implementation of short and longer-term corrective and improvement measures into standard project management practices.
Contribute to the standardisation of the project management best practices and seeking opportunities to harmonise processes and systems across programs

Minimum Requirements/Qualifications:
Bachelor's degree from an accredited higher learning program in Molecular Biology, Cell Biology, Biochemistry, Immunology or related discipline.
9 years industry experience including 5 year's experience in progressively more responsible project management roles required.
Previous experience in a regulated manufacturing environment.
Previous experience in academic research or biotech industry, preferably including familiarity with reagent production and QA/Regulatory standards.
Technical skills in laboratory techniques, manufacturing techniques, FDA & GMP compliance, especially DC.
Advanced understanding and ability adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics.
Demonstrated skills using MS Project or related project management software, MS Office, Outlook, and the Internet.
Strong understanding of product development challenges and methods for resolution.
Ability to resolve most day-to-day issues and develop mitigation plans.
Superior organisational skills with ability to multi-task and balance complex and routine work activities.
Demonstrated ability to lead program teams from concept to market successfully, direct and manage cross-functional teams and projects, influence business partners, get results through others and work effectively in a matrixed environment.
High-level business acumen.
Advanced presentation skills and interpersonal and communication skills, both written and verbal, with the ability to work as a team player and team builder.
Demonstrated experience using financial reports, budgeting and other related reporting tools.
Strong problem solving and scientific skills and ability to work independently.

Desired Qualifications:
An advanced degree in the sciences or an M.B.A. would be an advantage.
PMP (Project Management Professional) certification is a plus.
IVD Industry experience with proven history of delivering commercially successful results and working under Design Controls is a plus.

Top skills:
Senior Project Management (Complex, Cross-Functional Projects)
Regulatory & Quality Expertise (IVD / Medical Devices)
Business Transformation & Change Control
Excellent Gantt chart and critical path management skills; great attention to detail
Project Planning, Risk Management

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