Job Title: Project Management Senior Associate
Duration:12 Months
100% Remote position.
Standard hours: 8:00 AM – 5:00 PM local time (PST preferred).
Must be flexible for early or late calls due to global collaboration:
Earliest: 6 AM PST (rarely 5:30 AM PST once or twice per year).
Latest: 6 PM PST, typically 1–2 times per month (for Japan meetings).
Average 40 hours/week; no overtime expected without prior approval.
 
 
The ideal candidate is a detail-driven, globally minded Project Management Senior Associate with strong experience in change control and supply chain processes within a regulated pharmaceutical or biotech setting. They possess working knowledge of GMP/GDP standards, are adept at managing complex documentation and coordinating cross-functional change initiatives, and thrive in a matrixed environment with stakeholders across multiple time zones. A science-based thinker, heavy on experience over education in a technical or supply-chain-related field, this individual is proactive, flexible, and an exceptional communicator who ensures every change control activity meets quality and compliance expectations.
 
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 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
• 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.

 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, following SOPs, and learning from Supply Chain PMs, translating requirements into Change Control records = Customer Facing SKU Record (CFSCR) or Global Distribution Change Record (GDCR) that meets 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, supporting Launch or Variations of client products.
• Employee Value Proposition:     

.Possible Extension:       

• Yes

 Red Flags:          

• Lack of strong communication skills...this role partners with key Client staff from all Regions, Sites, and Corporate functions, globally. Clear, concise, communication is required to ensure strategies are understood and translated into Change Control documentation, which are then executed upon by many parties globally, to reach the end goal, shipping product to patients.
• Unable to manage/execute multiple project 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: $ 45.72/hr.