Helping organizations and individuals succeed.
Senior Labeling Manager
This is an exciting opportunity to work with one of the premier healthcare packaging contract staffing companies in the world supporting a variety of challenging strategic packaging initiatives.
The Senior Labeling Manager will work with a cross-functional team as well as various company stakeholders to ensure the timely revision of product packaging artwork and labeling in time to meet forthcoming regulatory compliance timelines for product identification and traceability. The manager will also lead and direct additional staff focused on label and artwork change management for regulatory compliance.
Network Packaging Partners is a rapidly growing management consulting and staffing firm. We embrace a 21st Century culture of collaboration, trust and innovative work arrangements. We help organizations and individuals succeed. We offer competitive compensation and a number of distinctive benefits along with flexible work arrangements. We’re committed to the professional and personal growth of our colleagues and provide hands on mentoring and coaching and support for our colleague’s desire to develop themselves. We invite you to explore what it’s like to be a colleague and grow with us.
Our client’s packaging and manufacturing operations organization is seeking multiple long term positions for the management and execution of labeling and artwork changes necessary to meet regulatory compliance.
The Senior Labeling Manager will work with artwork coordinators, package engineers, graphic specialists and project managers to ensure the timely revision of product packaging artwork and labeling in time to meet forthcoming regulatory compliance timelines for product identification and traceability. The client is also implementing a packaging component pharma code solution, which is also in scope for the foreseeable future. Specific responsibilities include:
- Assess the current status of artwork and labeling needs and identify gaps and recommendations on necessary resources.
- Create artwork and labeling revisions project plans to meet all project objectives for the defined scope of the projects; serialization compliance and packaging component pharma code implementation.
- Assist the client’s existing regulatory labeling organization in identification and selection of an enterprise solution for artwork and label management.
- Implement software system/process for managing all source data for product graphics and label content, manage work flow approval and of product and graphics preprinted label proofs, labeling and product labels.
- Manage qualification and/or validation of any systems or equipment necessary for graphics or label revisions.
- Understand and manage the documentation of change management of revisions to all product graphics, preprint labels, package inserts, eLabels and product labels via the client’s Trackwise solution
- Manage overall project schedule and produce monthly status reports relative to project schedule.
- Lead and direct additional staff, artwork coordinators, graphics designers and engineers respective of the project tasks and overall timeline of objectives.
- Communicate graphics requirements to and from suppliers and customers.
- Approve proofs from suppliers against graphics requirements and packaging material specifications.
The ideal candidate for this position possesses all the following:
- Working knowledge of manual and automated Label and Artwork Management Systems.
- Must have demonstrated ability to handle stress and quickly analyze problems in a professional and courteous manner.
- Familiarity with cGMP Change Control practices and related systems for regulated healthcare manufacturers (e.g. Trackwise or similar systems).
- Should have knowledge of U.S. and international government regulations regarding labeling requirements for pharmaceuticals and general regulatory knowledge.
- Must be detail oriented with excellent organizational skills, excellent communication skills; ability to make informed decisions; and ability to work well with others.
- Computer skills’, including word processing and ability to use various databases, is required.
- Excellent oral and written communication skills as well as extensive experience in leading and facilitating diverse teams, both face-to-face and in a virtual setting.
- Strong time and project management skills to allow for the ability to successfully track multiple project tasks at different times of completion.
- Must be comfortable communicating with and presenting to both peer-level team members and management.
- Must possess critical thinking and problem solving skills and have ability to complete assignments with limited guidance (self-directed).
- Knowledge and experience with various regulatory traceability requirements (Serialization) a plus.
- Experience working in central/regional above-site operations.
A minimum of an Associate’s degree in science, technology, engineering or math.
A minimum of 5 years of experience in pharmaceutical or medical device labeling and label and artwork management or packaging design and development related processes.
Remote w/ regular travel to Client’s North American locations. Candidate must be able to work in the US.
Up to 30% per month during the initial assessment phase (2 months estimated). Then, up to 10% on a monthly basis for duration of contract.