US Associate Project Manager, RAQA COE

This position is responsible for the supporting the development, implementation and management of Henry Schein's Center of Excellence Regulatory Affairs and Quality Assurance framework. This role will build structure and organization around the platform defining its purpose, direction, and motivation. The position will develop and standardize processes and procedures and coordinate internal and external resources to ensure that related special projects adhere to scope, schedule, and budget. This includes department development, partnership development, strategic planning, special projects, and the research and analysis of various program data and key metrics to develop reports for senior and executive management.

KEY RESPONSIBILITIES:

• Plan, manage, and oversee the daily workflow of the QA and RA functions, projects and audit schedule for the Center of Excellence.• Develop and implement the of goals, objectives, and priorities for the COE. This includes finalization of a Charter to include mission, goals and objectives. • Partnership development and strategic planning of special RAQA related projects with the various business entities. • Standardize procedures , in consultation with the process owners, to leverage across the business units to provide consistency in decision-making, accountability, stabilization and efficiency. • Identify and coordinate resources needed for projects, audits, etc.• Assist in the preparation of Monthly KPIs and Monthly Reports. • Assist with identifying improvement opportunities and efficiencies within and across the RAQA function• Develop and implement a standardized approach to research, monitor and disseminate regulatory intelligence. • Research information as required to develop regulatory intelligence.• Effectively communicate project information and progress to key internal and external customers.• Ensure project documents are complete, current, and stored appropriately.• Hold regular status meetings with COE team.• Assist is assessing the goals of the RA/QA Department to review for alignment with the needs and strategic initiatives of the respective business units.• Assist with and participate in a variety of quality and regulatory projects as required.

SPECIFIC KNOWLEDGE & SKILLS:

• An understanding of FDA Quality System Regulations (21 CFR 820) and ISO Standards (ISO 13485) is required.• Ability to prepare and pay invoices, schedule meetings, manage audit schedules, budget preparation, etc. • Working knowledge and application of regulations and guidance governing medical devices, drugs and other products manufactured and/or distributed.• Ability to standardize and leverage information and practices to support functional teams and business initiatives.• Team player and ability to collaborate with others to ensure timely completion of COE projects and goals. • Proficient in applying standard project management methods.• Good command of MS Office and common project planning tools used within the medical device industry.• Ability to organize and lead the COE members to drive timely completion of audits, inquiries, reports and projects. • Possess good conceptual skills and techniques.• Good verbal and written communication skills including public speaking skills.• Plan, manage and create strategy around complex projects; understand available resources, develop timeline, budget and assign areas of responsibility.• Communicate effectively with senior management and internal/external customers.

GENERAL SKILLS & COMPETENCIES:

• Excellent understanding of industry practices
• Strong proficiency with tools, systems, and procedures
• Strong planning/organizational skills and techniques
• Strong decision making, analysis and problem solving skills with ability to multi-task
• Excellent verbal and written communication skills
• Strong presentation and public speaking skills
• Strong interpersonal skills
• Strong conflict resolution skills and ability to deliver difficult messages
• Ability to build partnerships at all levels within the company, ability to build partnerships externally
• Good negotiating skills
• Resolve complex issues in effective ways
• Project management, consultative skills and ability to manage a budget

MINIMUM WORK EXPERIENCE:

Typically 6 to 8 or more years of increasing responsibility in terms of any applicable professional experience.

PREFERRED EDUCATION:

Bachelor's Degree or global equivalent in Sciences or Management or related disciplines. Master's degree or global equivalent preferred.

TRAVEL / PHYSICAL DEMANDS:

• Typically, no travel required.• Remote office environment. No special physical demands required.

While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 20 pounds

The posted range for this position is $83,520 to $146,160 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers