Manager, Business Transformation – Innovation
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $117,000 - $201,250 per year
About the role
- Acting as a point of contact for all CSC functional business process owners to ensure documentation readiness for audits and inspections.
- Ensuring necessary compliance documentation (procedures, instructions, templates, etc.) is established by the business process owners and readily available for the organization.
- Ensuring and maintaining a state of inspection readiness.
- Defining and monitoring key performance indicators and metrics to track process health & effectiveness.
- Driving continuous improvement & process optimization by using trending analysis & data to identify opportunities to improve & enhance while not comprising compliance.
- Acting as the liaison between multiple functional groups, inclusive of Global Development & Quality, to ensure effective communication on goals & requirements.
- Defining long term vision and roadmap, identifying opportunities for innovation & optimization.
- Facilitating a group of functional SMEs to drive areas of change.
- Ensuring strong Project Management and Governance processes are in place, and executed with appropriate controls, metrics, and leadership updates.
Requirements
- A minimum of 10 years experience in clinical or commercial drug product manufacturing or clinical trial materials supply is required.
- In depth knowledge on end-to-end supply chain processes is required.
- Project management skills are required.
- Highly organized, capable of managing multiple projects in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude.
- Demonstrated ability to collaborate internally and with external partners is required.
- In-depth understanding of relevant pharmaceutical legislation / cGMP regulations.
- Experience with Health Authority inspections.
- A minimum of 3 years of experience in a development environment is preferred.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementsupply chain processescompliance documentationkey performance indicatorsdata analysisprocess optimizationclinical trial materialsdrug product manufacturingcGMP regulationsHealth Authority inspections
Soft Skills
organizational skillscollaborationcommunicationleadershipteam managementproblem-solvingadaptabilitypositive attitudefacilitationcontinuous improvement