Compliance Program Manager Jobs in Decatur, GA (NOW HIRING)

Werfen is a growing, family-owned, innovative company founded in 1966 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 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 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 small to mid-size product development projects across multiple phases within a large multi-functional product development program; or plan and manage multiple small, related projects which together constitute a program. The position requires enthusias-tic leadership skills in a highly technical medical instrument product development environ-ment. The position requires regular interaction with all functions and levels of the organiza-tion from R&D scientists and engineers, marketing/sales, quality/regulatory, and operations, through executive management. Under the general oversight of a Senior Program Manager or Director of Programs, 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 required to carry out assigned duties, except where expressly reserved by the senior management personnel or Werfen Corporate /Divisional Policy.

Key Accountabilities

• 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, and develop and manage 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.
• Design Control: Creates and maintains file to current phase ensuring accuracy
• Communication: Responsible for program communication for both within the project team(s) and between the team(s) and executive management.
• Vendor Management: Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project.
• Cross Department Collaboration: Coordinates discussions with commercial functions (operations, regulatory, distribution, customer support, marketing, sales, service, affiliates, etc.). through established communication channels to support on market change(s) and/or new product introduction.
• 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
• Project/Program Initiatives: Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

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

• Coordination of review of documentation with Quality and Regulatory disciplines
• Communication of product changes with Manufacturing / Operations disciplines
• Communication of plans and status of projects with Marketing discipline
• Communication of plans and status with other programs and projects within R&D

Minimum Knowledge & Experience required for the position:

• BS in STEM field (engineering, biochemistry, immunology, etc.)
• Minimum of 7 years in project management or 5 years in product development
• Experience in design and development of in vitro diagnostic medical devices
• Experience in transfusion science or related field is desired
• Certification in project management or program management is desired

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

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
• Word, Excel, PowerPoint, Design Control

Travel requirements:

Less than 10% of the time.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

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 NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com