Director, Quality & Regulatory Business Development-2

Job Posting

Managing, analyzing, integrating and improving business development capabilities. Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

Roles and Responsibilities

Executes against the Quality & Regulatory Business Development Process. This includes scheduling, preparation, execution, reporting, and follow-up activities associated with Business Development activities; identification and communication of high-risk issues; reporting compliance concerns and recommended improvements to business leadership; developing and ensuring strategy is executed to current industry practices and regulatory expectations.

Standardization of processes, tools, and performance management system.

Requires ability to lead functional teams or projects with indirect resources and medium to high risk and / or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view.

Requires specialized depth and / or breadth of expertise within their discipline. May require strong commercial awareness and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.

Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GE HealthCare policy objectives.

Regularly advises Quality and Regulatory management in business development. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.

Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations.

Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results.

Required Qualifications

Master's Degree and a minimum of 7 years' experience in the medical device or pharmaceutical industry; or Bachelor's Degree and a minimum of 9 years' experience in the medical device or pharmaceutical industry; or will consider a High School Diploma and a minimum of 13 years' of progressive responsibility in the medical device or pharmaceutical industry. Minimum of 5 years' Experience driving Global programs to resolve quality compliance issues (directly). Experience with Pharma QMS requirements and regulatory requirements including but not limited to FDA 21 CFR Part 211 & 212, Eudralex and PICS.

Desired Characteristics

Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills. Demonstrated ability to analyze and resolve problems. ASQ Certification (CQE, CQA, etc.) and / or Lean Certification a plus (green belt, black belt). Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner. Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions. Strong oral and written communication skills in English. Integrity : Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others. Ability to travel domestically and internationally up to 20%.