Sr. Specialist, In-market Quality Indonesia

Job Description

The Position:

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

• The incumbent is responsible in ensuring that appropriate Quality Systems 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, while working within the bounds of the global Quality Management System in a state of GDP/GMP compliance.

• 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:

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

• 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 deployment and implementation of new / revised QMS policies, standards and global SOPs in the scope of medicinal products and medical devices.

• Establish performance management processes to monitor compliance and continuous quality improvements.

• Establish and maintain strong partnerships with key global/regional colleagues and teams that impact Quality and Compliance.

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

• Coordinate with RA and other related functions for HA communication and reporting HA notifications,

• Drive the development, implementation and realization of Permanent Inspection Readiness in collaboration with key stakeholders.

• Conduct and/or involve in self-inspection/internal audit and accommodate Organon global quality audit as well as HA inspection within the scope of Organon Indonesia Office and Organon Extended Warehouse.

• Involve in customer complaint handling in the market and perform necessary actions based on complaint trending data.

• Provide direction and collaborate with the respective external partners as Responsible Pharmacist to maintain compliance with Organon requirements as well as 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.

Required Education, Experience and Skills:

• At least a Bachelor’s Degree in Pharmacy, Pharmaceutical Science, or related field and completed Professional Degree of Pharmacist (Local Pharmacist license) with 5+ years of experience in Quality field.

• Solid knowledge of global cGDPs/cGMPs relevant to Marketing Authorization Holders and countries in scope.

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

• 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.

• Language proficiency : Native level Indonesian and Business level English

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1