QA/RA Program Manager I

7 months ago

Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen is a growing, family-owned, innovative company founded in in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7, strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary:

Plan and manage quality & regulatory projects across multiple phases within a large multifunctional compliance program; or plan and manage multiple small, related projects which together constitute a program. The position requires, enthusiastic leadership skills in a highly technical medical device quality & regulatory environment. The position requires regular interaction with all functions and levels of the organization from quality/regulatory, R&D, marketing/sales, and operations, through executive management. This individual directs the project team(s) in a manner to achieve the business results expected. Seeks and receives guidance on unusual and complex problems whose solution exceeds the approved project or program boundaries. Authority of position is that required to carry out assigned duties, except where expressly reserved by the senior management personnel or Werfen Corporate/ Divisional Policy.

Responsibilities

Key Accountabilities

Essential Functions:

Technical and Project Leadership: Provide technical and team leadership to one or more small project team(s) or a program team, including planning, scheduling, and technical leadership within the program area. Drive the successful attainment of program/ project goals. Project Planning and Scheduling: Responsible for project or program planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates an integrated project plan that meets business objectives and is in compliance with the design control process, while maximizing resource efficiency. Project Execution and Control: Responsible for conducting regular project or program team status meetings and reviews. Ensures deliverables are completed and documented. Identifies the need for and implements changes to the project plan that are within approved project boundaries. Plan and conduct major project milestone reviews. Problem Solving Leadership: Responsible for coordination of project resources to identify the root cause(s) of project issues, as well as developing and managing a plan to fix, test, and implement an appropriate solution through completion. Risk Management Leadership: Responsible for ensuring program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan. Regularly assess and report the status of overall program risk remaining on a program. Communication: Responsible for program communication within the project team(s), between team(s), and to executive management. Cross Department Collaboration: Coordinates discussions with commercial functions (operations, R&D, distribution, customer support, marketing, sales, service, affiliates, etc.) through established communication channels to support quality, regulatory, or compliance initiatives. Conflict Resolution: Able to resolve program and project team conflict through the application of good listening skills and negotiating skills. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the technical staff.

Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

Works with other sites/ functional areas to track and communicate program status Coordinates project dependencies and resources across multiple projects Reports aspects of projects and programs to senior staff regularly

Qualifications

Minimum Knowledge & Experience Required for the Position:

Bachelor's degree or higher in a relevant degree; a business, technical, or project management degree is preferred Minimum of 10 years in a project management role, or 7 years with an advanced degree Professional certification in project management or program management is desired Familiarity with quality and / or regulatory project environments preferred

Skills & Capabilities:

Leadership Skills Problem solving, conflict management, listening, managing and measuring work Strong project management skill set and familiarity with project management tools and techniques Team player, self-motivated, perseverance Strong oral and written skills Fluent with MS Word, Excel, PowerPoint, & Project Significant experience with project management approaches and concepts as well as some experience working across multiple project efforts

Travel Requirements:

Less than 10% of the time.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for

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