Executive Director Distribution & In-Market Quality

Organon LLC; Luzern; On-site; CHF 180,000 - 250,000; Full time

Job summary

Organon seeks a Distribution & In-Market Quality Lead to manage a global team of quality professionals across ~45 countries, ensuring cGDP and cGMP compliance for pharmaceutical products and medical devices. The role ensures quality systems are established and maintained, with effective oversight of local regulatory requirements and global standards.

Reporting to the Head of Quality, you will shape strategy, lead budget processes, drive performance management, and collaborate across functions to

Qualifications

• Bachelor or Master 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; must be able to apply sound risk management principles.
• 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 organisations 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 year's 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.

Responsibilities

• Leads the Distribution & In-Market Qualtiy organization globally.
• Oversees strategy, leadership, and budget controls for a multi-cultural quality team.
• Executes Employee Development Plan discussions and performance management.
• Contributes to DIMQ budget development and expense tracking.
• Demonstrates Organon Leadership Behaviors and leads by example.
• Collaborates with other functions to improve quality management and systems.
• Ensures alignment with global GDP/GMP/MD regulations and agency expectations.
• Establishes partnerships with global colleagues impacting Quality and Compliance.
• Implements new/revised QMS policies, standards and SOPs.
• Monitors compliance and supports continuous quality improvements.
• Communicates issues impacting Quality and Compliance.
• Provides leadership for significant investigations, fact findings, HA notifications, and market actions.

Skills

Leadership

Project management

Regulatory knowledge

Problem solving

Communication

Teamwork

Decision making

Diversity & development

Education

Bachelor or Master degree in a relevant field

Job description

Job Description Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants. Candidates may apply from any global location, regardless of the locations specifically listed in the posting.

The Position 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; ensures that appropriate Quality Systems are established, implemented and maintained, and appropriate oversight is in place to ensure that local regulatory requirements are compliant and can be supported in a simple, cost effective manner, while working within the bounds of the global Quality Management System.

Responsibilities

• Manages and leads the Distribution & In-Market Qualtiy (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 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.

Required Education, Experience, and Skills

• 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 organizations skills
• Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
• 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 organisations 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 year's 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.

Additonal information about the role

Additonal information about the role: Impact: This position will have direct impact on the quality, licensing and regulatory GDP/GMP/MD status of Organon products and processes. The incumbent is responsible for the establishment and maintenance of a robust Quality Compliance posture and will ensure that tools, resources and infrastructure are in place to support initiative realization. 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 while taking a holistic approach understanding the business impact of his/her decisions; must be able to apply sound Quality Risk Management principles. Influence / Liaisons: Must have the ability to be decisive and influence senior management across Organon internally and regulators externally with demonstrated leadership skills to drive change in Organon operations in a manner compliant with global regulations

Secondary Job Description

Who We Are:

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. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.

Our Vision is clear: A better and healthier every day for every woman.

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.

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas.

We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing.

Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today.

Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.

Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Regular Relocation: No relocation VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1