Role: Project Management Senior Associate
Location: Fully Remote
Duration: 12 Months (Possible Extension)
Preferred Time Zone: EST/PST
Ideal Candidate: 3–5 years of experience, lifecycle management knowledge, and experience with full product manufacturing stages.
 
Position Overview
The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for Customer Facing SKU control. This role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management and operational excellence to support the execution of product launches, variation implementations, and other activities related to the lifecycle management of Client products.
 
Specific Responsibilities 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
• 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

1. Change Control experience in Life Cycle Management, with Trackwise or other Quality System experience
2. Knowledge of GMPs and Biotech/Pharmaceutical Industry
3. Supply Chain and/or Quality background/experience, especially in Lifecycle Management

 
Certifications a plus:

• ASCM/APICS
• PMP

 
Day-to-Day Responsibilities

• Train and gain access to systems required quickly
• Work independently, absorbing knowledge and experience through participating in various strategy and execution forums/meetings for all products
• Follow SOPs and learn from Supply Chain PMs, translating requirements into Change Control records (CFSCR or GDCR) that meet required regulations, compliance, and GMP standards
• Ensure timeliness of activities by partnering with Assessors and Task Owners to ensure their activities are completed on time
• Support Launch or Variations of Amgen products

 
Red Flags

• Lack of strong communication skills
• Unable to manage/execute multiple projects concurrently
• Lack of analytical skills, science-based, pulling information from multiple sources
• Lacks flexibility to support PST or EST time zones

 
Interview Process

• Video Call Interview

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 49.31/daily.