Description:
Fully Remote - PST preferred
- Manage change control timelines with input from Variation Leads and/or Regional Operations Leads driving task completion across multiple functional areas
- Assure timely and fully compliant (RFT) maintenance of Change Control Management system related to Global Distribution Change Records (GDCR) and/or Customer Facing SKU Change Records (CFSCR)
- Provide timely updates to stakeholders, e.g., Regulatory, Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR readiness activities and related projects
- Represent the SCPM Hub in Project Planning meetings, Variation Execution Meetings and/or Regional Operations Team meetings
- Establish effective relationships with key stakeholders across multiple functional areas
- Identify and analyze complex problems and opportunities to streamline departmental activities and lead projects to drive improvements
- Create new procedures and processes to drive desired results
- Partner with all relevant stakeholders to share and implement best practices
- Proactively navigate a challenging and dynamic environment, with rapidly changing priorities
- Execute specific projects and business cases as required
- Works under minimal direction
Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Top 3 Must Have Skill Sets:
- Change Control experience in Life Cycle Management, with Trackwise other Quality System experience
- Knowledge of GMPs and Biotech/Pharmaceutical Industry
- Supply Chain and/or Quality background/experience, especially in Lifecycle Management
Below certifications a plus:
ASCM/APICS and/or PMP certification a plus.
Pay Rate between $52 - $59/hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"