Job Name:Project Manager & Continuity Expert
Location: Ridgefield, CT
Type: Contract
 
Overview
Join one of the largest pharmaceutical that is driven by science and seek to push the boundaries of what's possible in medicine and explore new options in life-enhancing treatments.
   
Responsibilities
The Business Development & Continuity Expert represents the Pharmaceutical Development department in audits and inspections by global regulatory authorities, collaborating cross-functionally with various global partners. They independently establish suitable systems and training for all IMP Delivery employees and team leaders, providing advice on compliance within the department. They independently introduce new processes and systems in IMP Delivery and other areas, coaching IMP Delivery employees and leaders on soft skills and the implementation and modification of new and existing processes. The expert independently leads all cross-functional Continuous Process Improvement (CPI) projects as a project manager.

Responsible for monitoring all archiving activities within the IMP Delivery and main contact person for all archive-related topics, processes, and OMS systems accessed by IMP Delivery.

Full responsibility and leadership of the SME team to ensure that the CPI philosophy is practiced in all IMP Delivery work packages conducted at the supplier, and that conceptual questions are addressed efficiently and promptly. Collaboration with GSPC, Sourcing, and Q&RM to ensure coordinated processes on behalf of the Pharmaceutical Development Department.

Independently represents the global IMP Delivery in both internal and external regulatory audits and inspections. Ensures that current supply chain information, processes, and SOPs are available and that inquiries and questions from auditors and inspectors are answered promptly.

Responsible for independent analysis and evaluation of temperature deviations in drug product logistics and storage, as well as initial assessment and documentation of deviations and complaints in the corresponding IT systems.

Independently and timely reports and handles deviations and CAPAs in the Quality System.

Responsible CPI project leader for innovation-related projects and provision of tools, project charters, as well as updates and training within the agreed timeframe with the steering committee and process owner.

Actively questions existing business models and processes and takes on the roles of coach and trainer during the introduction and implementation phase.

Continuously develops and generates new ideas and concepts within the supply chain process. Presents these ideas to the leadership team for further evaluation.

Conducts quarterly training for IMP Delivery business partners and GxP and HSE training for IMP Delivery as needed.

Responsible for maintaining the audit and inspection schedule and presenting the risk status to the management team to ensure that the IMP Delivery is in the best possible compliance readiness situation. Leading the Risk Management Committee and ensuring that actions are addressed in a timely manner and regular trainings and newsletters are published.
 
Requirements
The Business Development & Continuity Expert must be able to effectively lead teams, define tasks, clearly set expectations, identify measurable results, effectively handle conflicting situations, and express complex scientific principles in both German and English through presentations to internal and external partners. Leadership qualities are necessary.

In-depth knowledge and interpretation of GMP, GCP, and HSE guidelines, consulting, and Six Sigma Project Management training.

Minimum of five years in a similar environment for business development or consulting, demonstrating advanced knowledge in project management in an innovative and regulated environment.

Education:        
Master's degree in natural sciences or engineering.


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan

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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.