Project Manager - Packaging and Labeling

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.
PRIMARY FUNCTION:
Responsible to manage staff and lead a team of Artwork and Packaging specialists, oversee and manage the development of new and updated product labeling and change control packages, and ensure that documentation is appropriate, justified, and approved by responsible functional areas according to established procedures.Effectively represent Artwork & Packaging Department in cross-functional teams and actively participate with product teams to negotiate, plan, and assure on-time delivery of accurate labeling items. Successfully complete assigned and self-initiated projects.Initiate and manage continuous improvement projects including, but not limited to, labeling development that involves multi-functional or multi-site groups and issues.Demonstrate strong skills to identify and solve problems and to recognize and alleviate potential problems via continuous improvement initiatives.MAJOR RESPONSIBILITIES:
Responsible for implementing and maintaining the effectiveness of the quality system.Develop appropriate packaging for use in manufacturing operations and ensure accuracy of technical information regulated by the FDA and international regulatory agencies.Effectively manage and negotiate project time lines and priorities to assure on-time completion of projects.Balance, align, and prioritize day-to-day activities of core group to meet quality, customer, and business needs and to support overall Artwork and Packaging area objectives.Communicate and coordinate labeling and documentation approvals with other departments and sites.Actively manage and mentor staff of Production Artist and Project Coordinators. Foster open, appropriate communication within and outside of department.Builds high performance teams, maximizes the contributions of all team members. Supports the development of the teams vision mission, encourages collaborations.Makes timely decisions with the best available information and using the appropriate decision making processes.Manages Regulatory issues; identifies authenticates and responds to Regulatory issues in a professional manner, assembles appropriate resources to deal with and resolve situations effectively, lead by example.Anticipate long term future problems, resolve current issues, learn and adjust based on prior results.
Develop alternatives to major, strategic business problems. Coordinate the selection for the specific action plans that will best meet the identified long term business issues.Sets performance targets and growth plans for direct reports and conduct performance reviews.Promotes productivity cross functionally by exchanging information with appropriate frequency and timeliness to maximize outcomes.Delivers information, problems solutions, presents information to others in a manner that supports the project objectives while keeping in line with company goals. Responsible for ensuring information is received and understood.Translates Project goals as defined by the Artwork & Packaging manager, in line with company goals and day to day activities of the department.EDUCATION:
Bachelors Degree. Certification in Project Management will be considered.BACKGROUND:
Knowledge of regulations and standards affecting IVDs and Biologics.Must have the ability to problem solve, manage projects, influence internal and external groups, and provide leadership from an operations and quality perspective.Proven ability to successfully lead people and projects and to motivate and influence others are required. Productive supervisory experience is optimal.Over two years of experience in a technical, quality, or operations area and/or practical knowledge and skill sets in project management are required.Computer literacy in site software programs is optimal.Exhibit leadership and strong organizational and human relations skills.Demonstrate ability to interact and communicate with various levels of individuals and functional areas.Be a mentor/supervisor for other members of the department.Basic graphics design and printing industry knowledge are pluses.ACCOUNTABILITY / SCOPE:
Labeling and documentation for new products and revisions to existing labeling must be completed accurately and on time.Product quality is directly linked to the accuracy of the associated documentation. Inability to deliver per the schedule could result in a delay of product release, which can adversely affect product sales or postpone release of design improvement.Failure to produce accurate copy can result in loss of printed supplies and potential product recall or field action.Documentation associated with the labeling change control process must meet Quality, Regulatory, and GMP requirements.
Apply to: [Click here for email]Qualifications
EDUCATION:
Bachelors Degree. Certification in Project Management will be considered.BACKGROUND:
Knowledge of regulations and standards affecting IVDs and Biologics.Must have the ability to problem solve, manage projects, influence internal and external groups, and provide leadership from an operations and quality perspective.Proven ability to successfully lead people and projects and to motivate and influence others are required. Productive supervisory experience is optimal.Over two years of experience in a technical, quality, or operations area and/or practical knowledge and skill sets in project management are required.Computer literacy in site software programs is optimal.Exhibit leadership and strong organizational and human relations skills.Demonstrate ability to interact and communicate with various levels of individuals and functional areas.Be a mentor/supervisor for other members of the department.Basic graphics design and printing industry knowledge are pluses.ACCOUNTABILITY / SCOPE:
Labeling and documentation for new products and revisions to existing labeling must be completed accurately and on time.Product quality is directly linked to the accuracy of the associated documentation. Inability to deliver per the schedule could result in a delay of product release, which can adversely affect product sales or postpone release of design improvement.Failure to produce accurate copy can result in loss of printed supplies and potential product recall or field action.Documentation associated with the labeling change control process must meet Quality, Regulatory, and GMP requirements.
Bachelors Degree

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REQUIREMENTS
Please see Job Description