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Quality Project Manager

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

Position Summary

Responsible for implementing and maintaining the effectiveness of the quality system. Manages a single large project or several smaller related projects. Executes project management plan including all quality/regulatory requirements. Establishes project objectives and criteria for evaluating project results and activities of project team. Expedites, manages and coordinates a multitude of interrelated activities including QA/RA requirements within the constraints of limited human and financial resources and changing priorities. Supports division quality systems as defined in the Q documents. Transfers advances in technology into internal processes and procedures. Provides regulatory interpretation/guidance to worldwide sites. Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for area of expertise. Evaluates effectiveness of quality systems and programs. Supports implementation, training and monitoring of projects and programs to ensure that cGMP requirements are continuously being met.

Main Responsibilities

Coordinates input from multiple areas (e.g., functional areas, sites). Develops project objectives, strategies, timelines and milestones.

Translates project goals into project tasks.

Identifies resource requirements, costs, time schedules and need to develop relationships with contractors, vendors and/or consultants.

Develops an implementation plan, conducts risk assessments and develops contingency plans to accommodate unforeseen events.

Recognizes and removes barriers to project completion.

Recognizes the broader implications of actions and proposals on the final project outcome.

Prepares and presents project progress reports to keep management and team informed.

Applies advanced technical writing skills to produce reports and documents.

Writes independently and critically evaluates the writing of others.

Identifies problems and works to resolve them.

Analyzes data using basic procedures and techniques for identifying true causes of problems.

Has a thorough theoretical and practical understanding of a technical discipline and applies practical and theoretical knowledge to solve assigned problems.

Maintains a technical currency in the assigned discipline.

Anticipates, recognizes and communicates quality issues to the appropriate organization and develops actions to resolve the issues.

Identifies broad process improvement initiative opportunities.

Solicits the cooperation of a diverse group of disciplines and functions in a tactful and persuasive manner.

Leads others in the completion of project tasks and sub-projects.

Draws on technical expertise available within and outside of Abbott.

Manages the decision-making process.

Creates a work environment that supports team effectiveness.

Builds effective teams, assesses team performance and makes adjustments when required.

Achieves goals through interaction with individuals not under direct supervision.

Functions as the subject matter expert and role model, worldwide, for area of responsibility.

Assists sites in understanding and deployment of quality system requirements/policies.,Interfaces with other disciplines, internal customers, cross-functional project support personnel and internal/external experts, as required.

Creates a climate of trust and respect within the project team and resolves conflicts affecting project completion.

Removes barriers impeding the progress of projects.

Prepares and presents written and oral reports and other presentations to internal and external audiences.

Adjusts presentation style and content to suit the audience.

Assists functional areas and sites in understanding the quality system requirements and translation of the requirements into site-specific procedures.

Interprets Results / Recommends options: Interprets data, draws conclusions and recommends options for next steps; Expands Analysis: Uses or gets additional data to confirm the impact of an issue on other parts of the organization.

Devises strategies to obtain appropriate data to further define and resolve issues.

Draws inferences: Assimilates information from multiple sources, and draws inferences.

Analyzes Relationships: Identifies cause-effect relationships and uses understanding of organization processes and culture to recommend options.

Establishes Goals and Develops Plans: Provides conceptual framework for plan; defines milestones; reviews project load and recommends resources needed to complete project; reviews status; suggests revisions to plan as necessary; develops cost analysis/recommends budgets.

Adjusts Plans: Analyzes plans to ensure that they are feasible within resource constraints; applies experience to review and adjust plans to meet overall business objectives.

Integrates Multiple Project Plans: Makes plans to accomplish multiple activities and projects, establishes priorities to handle competing demands, optimizes use of available resources, estimates time and resources necessary to complete tasks or projects; works on improvement and development of new planning processes. Implements Multiple Project Plans: Implements project plans to meet project goals; considers technical, resource, and regulatory requirements to meet complex project goals.

Continuously Improves: Recommends innovative ways to improve performance and quality on an ongoing basis in line with current ADD quality and regulatory requirements.

Allocates Resources: Appropriately prioritizes tasks and negotiates resources to achieve desired outcomes.

Manages Change: Evaluates the impact of business, industry, and regulatory changes to the project and adjusts implementation activities to meet revised schedules.

Maintains Documentation: Maintains appropriate documentation so that materials are traceable and processes are transferable.

Fosters a Quality Attitude: Follows and contributes to policies and procedures; gathers data for and contributes to establishment of quality metrics to support projects and to evaluate Quality System effectiveness; monitors and takes corrective actions for the system/project; assists with translating regulatory requirements and/or standards into the Quality System.

Fosters Information Exchange: Promotes productivity cross-functionally by exchanging information with appropriate frequency and timelines to maximize its utility.

Adapts Information to Customer Needs: Delivers communications tailored to the needs of the receiver (managers, peers, customers) e.g. delivers only important information and sends it via the correct medium (written, oral electronic); uses appropriate language and level of detail for the receiver; provides specific feedback to others, writes clear executive summaries and persuasive proposals.

Delivers Information: Identifies and communicates problems and solutions; presents information to others in a manner that supports organizational objectives; identifies the appropriate recipients for information.

Actively listens: Listens actively to acquire information and understand the other person’s viewpoint.

Builds Relationships: Initiates and cultivates open, honest, and beneficial relationships with colleagues and customers by establishing rapport, developing an understanding of other‘s needs, promotion common goals and following through on commitments.

Resolves Conflicts: Faces conflicts and takes initiative to resolve them constructively; diverts tensions away from individuals and towards work issues; probes for root causes of problems, collaborates to find mutually beneficial solutions, proposes action steps and assists in implementation.

Collaboratively settles disputes.  Confronts Issues: Confronts issues in a constructive manner and at an appropriate organizational issue.

Maximizes Productively: Actively shares resources, ideas, facilities, and data to accomplish goals requiring cross-functional collaboration and support.

Makes Decisions: Makes timely decisions with the best available information.

Influences Outcomes: Uses constructive techniques to persuade, convince or influence others to follow a plan of action.

Influences across functions without authority; sponsors innovation and initiative among teams; inspires commitment and action.

Negotiates: Defines the business needs of various parties; secures agreements and achieves results; achieves win-win decisions when possible.

Provides Direction: Communicates a focused vision/direction for the team and motivates people to believe in it.

Acts as a role model and leads by example.

Provides Change Leadership: Recognizes and rapidly responds to changes in regulations and business needs; identifies project teams strengths and weaknesses and makes adjustments to meet project goals.

Manages Crises: Identifies, authenticates and responds to crises in a professional manner, assembles appropriate resources to deal with and resolve the situation effectively; keeps emotions in control during periods of high stress, leads by example.,Builds High Performance Teams: Maximizes the contributions of all team members.

Facilitates Teamwork: Supports the development of the team's vision/mission, links team mission to division and organizational missions; encourages collaboration; works with team to clarify roles and expectations; works just as effectively as a member or as a leader.

Promotes a Teamwork Environment: Involves team in planning, problem solving and decision making; celebrates successes; fosters open dialogue; sets the example to work cooperatively with multi-disciplinary and diverse groups; encourages the development of team-based rewards and recognition.

Empowers the Team: Delegates tasks or projects to the team and provides appropriate authority, responsibility and direction to complete them.

Manages Performance: Sets performance targets for the team; helps the team understand metrics for evaluating performance.

Inspires high performance by holding team accountable for key results; evaluates milestone achievement and addresses issues through appropriate channels.,Receives/Gives Feedback: Asks for and gives feedback on the strengths and development needs of self.

Identifies Future Development Needs: Translates changes in business goals and objectives into the skills, knowledge and experience needed for future work.

Achieves Development Goals: Balances the time needed for accomplishing current work and achieving development goals and applies newly developed knowledge, skills and experience to the job.

Quantifies Risk: Identifies and quantifies risks relative to the success of an overall project and takes appropriate action.

Evaluates Risk Levels: Assesses risks within established parameters; recommends actions and develops responses to cope with various scenarios; recognizes when risks associated with decisions exceed limits and escalate; seeks approval when issues remain unresolved.

Stays Current: Understands and applies current policies and procedures.

Monitors Trends: Demonstrates awareness of changes in the quality and regulatory environment, as well as science, industry, competitors and companies.

Anticipates Future Directions: Identifies quality and regulatory trends to contribute to the development of long-term business strategies; anticipates future directions in regulatory requirements and scientific advances; provides input to the appropriate business areas. Translates Business Strategy: Translates regulatory requirements and ADD's goals into the day-to day activities necessary to accomplish them.

Accountability

Negotiates project outcomes and deliverables to meet the conflicting demands of time, money and deadlines.

Monitors actual versus planned expenditures.

Recommends process improvements to accelerate project progress.

Functions as the project contact with third party vendors.

Accountable for total project scope, completion within budget constraints and scheduled completion date.

Accountable for successful completion of project tasks under direct or matrix control.

Level loads work to ensure effective use of available resources.

Influence and visibility on supported projects and activities extends to multiple sites.

Makes independent decisions within defined parameters related to project responsibilities.

Qualifications

Knowledge of regulations and standards affecting IVDs and Biologics. Bachelor’s degree in an engineering, scientific or technical area with 3-5 years of experience in an area related to the project. A minimum of 5 years’ experience in manufacturing operations or quality systems with a thorough understanding of Abbott internal systems and procedures. Has led at least 1 significant project from beginning to end. Recognized technical and project management skills appropriate to the project. Technical experience and demonstrated competence in multiple areas of responsibility (e.g., functional areas, sites, divisions). Demonstrated diplomacy and effective functioning in a matrix environment. Working up-to-date knowledge of quality system regulations, ISO 9000 requirements and corporate policies, standards and requirements.

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