Project Manager (JP8438)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Project Manager
for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- Seeking candidates with quality, operations, and supply chain.
- Biotech/Pharma experience preferred.
- Translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control.
- May also translate product variation strategy as determined by the Regional Operations Lead to an executable implementation plan for 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 the 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 on status of GDCR and/or CFSCR readiness activities and related projects.
- Execute specific projects and business cases as required.
- Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
- Create new procedures and processes to drive desired results.
- Identify and analyze complex problems and opportunities to streamline departmental activities and lead projects to drive improvements.
- Partner with all relevant stakeholders to share and implement best practices.
- Establish effective relationships with key stakeholders across multiple functional areas, both on site and virtually.
- Proactively navigate a challenging and dynamic environment, with rapidly changing priorities.
- Works under minimal direction
Doctorate Degree OR Master's Degree and 3 years of operations or supply chain experience OR Bachelor's Degree and 5 years of operations or supply chain experience OR associate degree and 10 years of operations or supply chain experience OR High school diploma/GED and 12 years of operations or supply chain experience
- Change Control experience in Life Cycle Management, with Trackwise or other Change Control System experience
- Knowledge of GMPs and Biotech/Pharmaceutical Industry
- Supply Chain and/or Quality background/experience
Employee Value Proposition:
- 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 Launches or Variations of the client products.
Dynamic team and chance to work with multiple teams.
Lack of strong communication skills. This role partners with key the 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 multiple projects simultaneously.
Panel interview WebEx.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.