Senior Specialist, Quality Responsible Person

Job Description

The Position

• The In-Market Quality Vietnam, Quality Responsible Person as well as Responsible Pharmacist for Organon Vietnam reports to In Market Quality AP(SG/ID/VN/HK) Sub Cluster Lead.

• Responsible in ensuring that appropriate quality aspects of GSP warehouse for medicines and medical devices are established, implemented and maintained in the 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.

Responsibilities

• This role involves handling Foreign Invested Enterprise (FIE) warehousing and distribution process, product release, inventory management, as well as managing daily operational tasks to ensure that processes and products within the market’s scope meet quality standards and are effectively distributed to meet customer needs.

• Build and maintain the Quality Management System (QMS) in accordance with Good Storage Practice (GSP) guidance and Organon QMS.

• Ensure deployment and implementation of QMS established in Organon Vietnam and take appropriate corrective action and preventive action for deviation and improve the QMS and/ or process when necessary.

• Ensure regulations pertaining to Quality and Compliance for importation and warehouse (WH) operation including goods receipt, storage, dispatching and delivery at WH (e.g. GSP guidelines and Vietnam regulatory requirements, where applicable) are fulfilled as per Organon Vietnam business model.

• Coordinate with Regulatory Affairs and other related functions for Health Authority (HA) communication and reporting regarding Quality and Supply issues.

• Work 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 Quality perspective is brought into Organon Vietnam initiatives with Quality impact.

• Provide leadership and oversight for Significant Investigations and Fact Findings, lead & coordinate with related departments in terms of Market Actions and Product Recall execution.

• Provide direction and collaborate with the respective external partners as Responsible Pharmacist to maintain compliance with Organon requirements as well as Vietnam local regulations. This includes conducting customer qualification in the form of customer verification and audit process while adding, updating and maintaining customers by the Organon entities that are in scope.

• Primary country contact for Organon Manufacturing Supply (OMS) Quality and Health Authority in relation to Organon Vietnam.

Required Education, Experience and Skills

• At least a Bachelor’s Degree in Pharmacy

• Must be locally registered pharmacist with a valid registered pharmacist license. The position will be one of the Registered Pharmacist.

• Minimum of 5 years’ experience of professional practice at an appropriate pharmacy establishment (preferred in the pharmaceutical industry).

• Must have expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global Good Manufacturing Practice (GMP) and Good Storage Practice (GSP).

• 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.

• Strong ability to work with SAP and comfortable with data-driven analysis and decision making.

• 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. Experienced in Supply Chain or Regulatory Affairs within Pharmaceutical industry is advantage.

• Strong interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures with commitment to diversity and employee development.

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

10%

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1