Job Description

Title:

Site Quality Head, Menuma

Department:

Quality Operations

Reports to (title):

AVP of Quality, Device and Packaging Platform

Division:

Our Manufacturing Division

Position Overview - Basic Functions & Responsibility

                    

As site Quality lead, the incumbent is responsible for leading site quality activities and behavior, establishing quality management system and ensuring it’s operated effectively, to ensure the product quality and site operation in accordance with the GMP regulations in Japan & Quality Management System in our company.

The incumbent is responsible for leading site quality operation’s department’s routine operation and people management, including quality operations and quality control, supporting site operation ensure the product quality and GMP compliance.

In addition, the incumbent is acting as primary contact of communication between site and external quality units, Japan Quality & Compliance and our company global functions. Also the incumbent along with Certified Pharamasict is the primary contact for local regulatory bodies. The incumbent is the owner of Menuma plant QMS systems-Quality Management.

Primary Activities        

-Strategy

1. As part of the site leadership team, develops and deploys site level strategies in alignment with divisional and local our company objectives.

2. Work with site leadership team to develop and implement strategy with specific focus on improving compliance and improving 

    efficiency of how the QMS are implemented.

3. Develop MPS/kaizen mindset in quality and works to optimize the quality related operations through identification and 

     implementation of efficiency in quality operations and ensuring Right First Time. Ensures that MPS standards are adhered to within the Quality Organization.

-Quality and Compliance

1. As system owner for the Quality system while leading the site in ensuring it is operated in compliance with the entire QMS system and with Japan regulatory requirements, through GMP training, internal audit program, quality metrics and CAPA.

2. Act as primary contact of communication between site and external entities, and corporate closely with internal and external entities during daily operations, new product launches and audits.

3.  Be responsible for the operation of site quality council, assessing significant quality risk incident and ensuring the rationality of quality decision.

4. Make sure raw materials, packaging components, intermediate products, semi-products and finished goods are managed per quality standard and production procedures, to be in accordance with our company and Japan filing requirements.

5. Confirm and monitor material and products storage and operational conditions.

6. Be responsible for release or reject decision of material and products. Ensure all necessary test and batch record review are completed prior of product release.

7. Review and approve all quality related significant changes.

8.  Establish and manage site deviation and customer complaint investigation system, ensure all the significant deviation and OOS are investigated and handled timely. Ensure that internal and external supplier quality issues are managed appropriately to our company standards.

9. Ensure all product quality related complaints are investigate and handled timely and correctly.

10.Ensure all GMP suppliers are well managed and audited per our company requirements.

11. Supervise the maintenance of facilities and equipment, to ensure those in good status.

12. Ensure necessary qualification & validation is conducted to critical buildings, facilities and equipment.

13 Ensure completion of product stability study program on time.

14. Ensure the completion of product quality review and analysis.

15. Ensure necessary pre-job training and continuous training are provided to site employees conducting GMP activities, and make sure necessary changes are made to reflect current needs.

16. Ensure site record management is in compliance with GMP and our company policy’s requirements.

17. Supports Supplier Management Program and Ensures Supplier Quality management standards are met in terms of quality agreedments, supplier specifications, inspection reporting and suppler performance management.

18. Ensure changes related to GMP activities well documented, accssed for impacts on quality & compliance posture, evaluated based on necessity and priorities.

-Safety

Responsible for the overall safety management within the department adhrering to SBC Guidelines.  Ensures Safety awareness and appropriate safety behaviors are maintained at all times.    Direct departmental safety work with the following responsibilities:

Sponsors and leads implementation and realization of safety rules and procedures within the department.  

Ensures that staff use personal protective equipment as required.

Encourage staff to attend relevant safety training.

Ensures timely and honest report of safety accidents and promote investigations.

Responsible for department employee firefighting education, ensure employee understand job firefighting responsibility and skills of raising fire alert and usage of fire equipment; Ensure the laboratories are operated in a safe manner and in compliance with EHS internal and external regulations. Ensure implementation and maitenence of operation and seating areas are fully 5S complaint.

-Operations

1.Lead the quality team ensuring product testing and release schedules are met to support the site delivery targets.

2.Be responsible for the operations and maintenance of the site laboratories.

3. Interact effectively with the broader Quality organization including managing issues of escalation or market impact.

4. Understands and complies strictly to the GMP requirements. Ensures that all departmental GMP activities are compliant

5. Supports the work of quality department. Maintains effective communications with quality department and across functions.  

6. Establishes a sound quality culture in the department. Provides enough resources to ensure the drugs are produced according to customer's requirement and government regulations.

7. Ensures that standard capacity model is developed and maintained tracking carefull operational standards linked to financial reporting and ensures that workload is level-laoded with resource plans.

8. Leverages MPS as the how in terms of daily operations management – man, machine, materials, management system, operating system and mindsets and behaviors.

-People Management

Ensure effective human resource management in Quality, through execution of capacity and demand management in each quality function. Placement of performance management, compensation, training, development, talent management and employee relations processes, to build leader skills and employee engagement and capability. Create a high-performance organization through building inclusive environment with high levels of employee engagement. Delegates and pushing down decision making to most appropriate level, fostering an environment where employee engagement, empowerment and accountability as the cultural norm. Encourage ‘all are decision makers’ mindset in Quality organization (including labs). Strengthen Diversity & Inclusion behavior throughout the organization. Build organization strengthening lean leadership/management and decision-making mentality considering E2E process of products/systems. Develops and coaches key talent and builds depth and strong succession plans at all levels.

-Finance

Manage Quality budget within the local and global targets and manage visibility to flow. Sponcer and encourage to identify and implement productivity improvement activities at all level within quality organization. 

Skills & Competencies:

Self:

Maintaining his / her skills and knowledge on quality systems and regulatory framework up to date and promote a culture of continuous learning Demonstrates leadership behaviors in alignment with the our company leadership standards. Develops and updates performance objectives and accomplishments in Workday system and hold discussion on Employee Development Plan (EDP) for key roles in organization aligned with Performance Management Process. Ensures both operational knowledge and technical skills are maintained and compliant with individual training requirements.

Technical Responsibilities:

Knowledge in more than one key function area of solid oral dosage manufacturing/packaging operations/ Devices (e.g. manufacturing, Technical Operations, Supply Chain, etc.) Knowledge in fields of quality operations, quality management systems, lab systems. Knowledge on Japan regulatory requirements in GMP environment Knowledge on fields of EHS, Operational Excellence (ex. MPS), Lean Manufacturing, Continuous Improvement

Business & Leadership Responsibilities:

Capacity to be a change agent Displaying high integrity and honesty Capacity to think and act strategically Results driven, resilience Business acumen and understanding of all financial aspects linked to role Problem Solving and Decision-Making skills Planning and Organization skills Written and spoken communication skills in both Japanese & English Ability to motivate group whilst keeping focused on objectives  Ability to act as coach and mentor Continuous Learning

Minimum Requirements  

Education:   

Degree in pharmacy, Chemistry, Chemical Engineering or equivalent degree.

Experience:  

12 years of pharmaceutical experience with a minimum of 5 years of quality operations, manufacturing, packaging supervisory management experience with increasing levels of responsibility; experience in more than one functional area.

Specific Knowledge:  

Regulatory & Quality Management Systems, Pharmaceutical Processing, Effective communication skills, Talent development and Organizational design skills, Good English & Japanese Knowledge, Continuous process improvement, Problem solving capability

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. 

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R335317