- 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
- 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
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Project Management Senior Associate - Thousand Oaks, United States - Aditi Consulting
Description
Summary: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's products.
Responsibilities:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.