The Position
The In-Market Quality, AP(SG/ID/VN/HK) Lead reports to AP In-Market Quality Lead.
The incumbent is a leader of a team of 2-3 quality professionals responsible for In-Market Quality activities and maintains the affiliates within the cluster of countries in scope, in a state of GDP (and where applicable, GMP) compliance.
The incumbent provides overall leadership and direction, coaching and training to the local In-Market Quality team; ensures that appropriate Quality Systems are established, implemented and maintained in each market in scope, 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 incumbent liaise with Global Quality, External Manufacturing Quality, the Quality Units of the manufacturing network, Regulatory Affairs / Pharmacovigilance and Supply Chain to support the commercial activities while maintaining Quality and Compliance.
Responsibilities:
Responsible for the strategy, leadership, management and budgetary controls of a 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 AP IMQ budget and tracks and controls expenses as needed to meet AP IMQ budget.
Exhibits our company Leadership Behaviors and provides a leadership example for the team.
Works strategically and in collaboration with other functions to continuously improve our company`s effectiveness and efficiency in quality management and quality systems supporting AP IMQ function.
Ensure alignment of Indonesia, Singapore, Hong Kong and Vietnam market with applicable global GDP/GMP regulations, global quality systems and with agency expectations.
Establish and maintain strong partnerships with key global/regional 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.
Provide leadership and oversight for Significant Investigations, Fact Findings, HA notifications and Market Actions.
Drive the development, implementation and realization of Permanent Inspection Readiness in collaboration with key stakeholders.
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 Authorizatin 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
Preferred Education, Experience and Skills:
Minimum of 5 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 GDP and regulatory requirements.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $
- 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 Womens 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.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at [Confidential Information].
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:
International
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
Requisition ID:R528619
