Project Management Specialist

Project Management Senior Associate with Change Control, Trackwise/Veeva and Pharma/Biotech Experience (100% Remote Job)

Location: Thousand Oaks, CA

Terms: Contract W2

Duration : 12 Months Contract (Will Get Extended for Long)

Overall client need someone who has Quality Assurance Project Manager or Quality System Project Manager

SKILLS

1) Change Control experience in Life Cycle Management, with Trackwise other Quality System experience

2) Knowledge of GMPs and Biotech/Pharmaceutical Industry

3) Supply Chain and/or Quality background/experience, especially in Lifecycle Management

Below certifications a plus:

ASCM/APICS and/or PMP certification a plus.

Description:

Fully Remote - PST Preferred but not required

Ideal candidate - 3-5 YOE, lifecycle management knowledge of full product manufacturing stages experience.

SPECIFIC RESPONSABILITIES INCLUDE BUT ARE NOT LIMITED TO:

•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