Head of Distribution & In-Market Quality

Job Description

Location is not a restriction the role can be done anywhere globally and not limited to the primary location.

The Position

The Distribution & In-Market Quality Lead reports directly to the Head of Quality. The incumbent will lead a global team of approximately 100 quality professionals across approximately 45 related entities 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 (where applicable) 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.

The role has additional responsibility for leading the Localization Platform (previously under External Quality Assurance/EQA) that is responsible for quality oversight of the external entities performing bulk drug product and medical device manufacture, packaging, and distribution specific to local and/or regional markets. It is also the quality partner in business development deals for local markets. This is being moved under DIMQ given its local/regional focus and close alignment with other in-market quality assurance activities.

Responsibilities

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. Lead and manage the Localization platform providing quality oversight of the external entities performing bulk drug product and medical device manufacture, packaging, and distribution specific to local and/or regional markets. It is also the quality partner in business development deals for local markets.

Required Education, Experience and Skills

• Bachelor's or Master's 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 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.

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. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1