CONTRACT POSITION W2 ON-SITE POSITION IN RIDGEFIELD, CT 06877 PAY RATE RANGE UP TO $63.00 PER HOUR (DEPENDING ON EXPERIENCE LEVEL) Clinical Trial Supply Chain Project Manager needed in Ridgefield, Connecticut 06877 for a long-term contract opportunity with Yoh's client. The Big Picture Top Skills You Should Possess:
- Regulatory audits and inspections
- Compliance
- Continuous process improvement
- Project management
- GMP, GCP, and HSE guidelines knowledge
What You'll Be Doing:
- Represent the Pharmaceutical Development Department in audits and inspections by global regulatory authorities, collaborating cross-functionally with various global partners.
- Independently establish suitable systems and training for all IMP Delivery employees and team leaders, providing advice on compliance within the department.
- 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.
- 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.
What You Need to Bring to the Table:
- Master's degree in natural sciences or engineering
- 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.
- 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.
What's In It For You? We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
Opportunity is Calling! Apply Now for the Clinical Trial Supply Chain Project Manager position in Ridgefield, Connecticut 06877 for a long-term contract opportunity with Yoh's client. Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Estimated Min Rate: $55.00 Estimated Max Rate: $63.00Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit to contact us if you are an individual with a disability and require accommodation in the application process.For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.