[Hiring] Executive Director Distribution & In-Market Quality @Organon

Role Description

The Distribution & In-Market Quality Lead reports directly to the Head of Quality. The incumbent will lead a global team of approx. 85 quality professionals across approx. 45 countries responsible for Distribution & Supply Chain Quality and In-Market Quality activities. The incumbent provides overall leadership and direction, process and governance to distribute, store & release products in all markets to maintain a state of cGDP and cGMP compliance for Pharmaceutical Products and Medical Devices.

• Manages and leads the Distribution & In-Market Quality (DIMQ) organization.
• Responsible for the strategy, leadership, management and budgetary controls of a global, multi-cultural team of Quality professionals.
• Holds Employee Development Plan discussions and is responsible for executing the performance management process.
• Contributes to the development of the DIMQ budget and tracks and controls expenses as needed to meet DIMQ budget.
• Exhibits Organon Leadership Behaviors and provides leadership example for the team.
• Works strategically and in collaboration with other functions to continuously improve Organon’s effectiveness and efficiency in quality management and quality systems supporting DIMQ.
• Ensure alignment of the Distribution & In-Market Quality with applicable global GDP/GMP/MD regulations, global quality systems and with agency expectations.
• Establish and maintain strong partnerships with key global colleagues and teams that impact Quality and Compliance.
• Ensure deployment and implementation of new/revised QMS policies, standards and global SOPs.
• Establish performance management processes to monitor compliance and continuous quality improvements.
• Effectively communicates issues which impact Quality and Compliance.
• Provide leadership and oversight for Significant Investigations, Fact Findings, HA notifications and Market Actions.

Qualifications

• Bachelor or Masters Degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent).
• Solid knowledge of global cGDPs/GMPs relevant to Marketing Authorization Holders and countries in scope.
• Strong compliance mindset, excellent project management and organizational skills.
• Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments.
• Ability to be decisive and influence management with demonstrated leadership skills to drive change.
• Ability to work collaboratively in team settings, across functions, and within matrix organizations to achieve objectives.
• Strong commitment to diversity and employee development.
• Strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures.
• Demonstrated ability to create simplicity out of complex environments and challenges.
• Minimum of 15 years' experience in the pharmaceutical industry, with solid compliance experience.
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global cGDP, cGMP and regulatory requirements.

Requirements

• Impact: This position will have direct impact on the quality, licensing and regulatory GDP/GMP/MD status of Organon products and processes.
• Decision making: This position will work independently with all levels of the organization on a global basis and will have the decisions on compliance on a global basis.
• Problem solving: Must have excellent problem solving skills, based on science, facts, data and understanding of global regulatory requirements in complex and evolving environments.
• Influence / Liaisons: Must have the ability to be decisive and influence senior management across Organon internally and regulators externally.

Benefits

• As an equal opportunity employer, we welcome applications from candidates with a diverse background.
• We are committed to creating an inclusive environment for all our applicants.

Company Description

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. Our Vision is clear: A better and healthier every day for every woman.