Job description

REMOTE - any US time zone is OK

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 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

•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

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

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 organizational skills.

Candidate must have analyatical experience

Job Type: Contract

Pay: $45.00 - $55.00 per hour

Schedule:

• 8 hour shift

Experience:

• Change management: 2 years (Required)
• Product lifecycle management: 2 years (Required)
• CGMP: 2 years (Required)
• Trackwise: 2 years (Required)
• Analytical skills: 2 years (Required)

Work Location: Remote

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