QA senior staff

Job Description:< Role Purpose Statement>

This is an exciting important managing role of Ferring Pharmaceutical to have the following GQP and QMS activities Roles supervising by GQP quality responsible person (Hinseki) and head, Quality Management as well as leading Ferring Japan strategic projects.

​​GQP operational roles & New Product Introductions

As one of GQP responsible roles, MAH’s GQP activities role for entire GQP operation (Change Management, Quality Documentations, Deviation Management, Complaint Management, Deviation, supervising local CMO and oversea MFG sites (internal and external), SQM and so on) for Ferring products in order to ensure the full compliance of applicable GxP regulations in Japan & global (Such as GQP and GMP ordinance), Corporate & local Policies, Standards and SOPs and applicable global GxP guidelines.

Especially for upcoming product introductions, (at least) two products will come under GQP controls. Those additional tasks will be effectively absorbed as a team with this new role (Eg. the number of release handling could be added aprox. A few hundreds of batches per year/2025. The number of complaint handling will be increased as + 20 cases per year etc.

Lead and manage strategic local projects from quality perspectives

Ex1. “local CMO optimization project” to work with local SCM team closely in order to identify the suitable key CMOs via assessment (as part of SQM system), once identified key CMOs via optimization project, to provide sufficient guidance to the CMOs from quality/GMP and communicate with CMOs closely under GQP controls.

Ex2. “Clean up legacies” (untreated TW cases and completion of GQP records, maintaining quality documents) to improve regulatory compliance status to comply with GQP ordinance and local regulation

Ex3. “Local Change Management Committee Activities“ to work with RA and SCM team to assess & clarify the global/local change cases, identify the required actions, Communicate with internal/external stakeholders

 and so on.

QMS organizer role

Which is part of global quality and GQP role to organize the corporate and local quality policy and relative QMS system (Electric Document Management System/Veeva, Learning management system (LMS) and TrackWise system. This is a collaborative role working with entire employee (M&S, R&D) supervised/supported by QMS manager (who is another division of QM department and lead to QMS activities), GQP responsible, QM head. This role maintains QMS system which applies for GxP activities and Ferring Quality activities.

Others Cross functional Project Activities (if applicable/assigned) to provide quality guidance etc.

*Quality Management department which is the only quality unit of MAH of Ferring Japan is divided into two groups: “Development Quality Compliance and QMS” and “Quality Assurance for marketed products as GQP function”.

< Main Accountabilities (duties and responsibilities) >

1. Execute and manage GQP-required quality assurance tasks (see below) including supporting tasks along with lead responsible in QA team and QMS tasks independently.

• Documentation (Quality Product Codes, QTA GQP SOPs) *QTA : Quality Technical Agreement “Hinshitu Torikime”
• Product GQP Release (if applicable, Depending on the level of experiences and knowledges)
• GMP sites control including Change Management, Deviation/OOS Management, APR, GMP audit report and various validations reviews etc.)
• Quality Information including Customer complaints, product recall handling
• GQP Self inspection, Corporate internal audit, Quality Review Board Activities
• Training activities for GxP regulations
• GQP audits/GxP audit (if applicable)
• Others (Gap analysis between approval documents and actual MBR/BR in manufacturing process and analytical Spec and method, Quality Performance Indicator Monitoring, Quality Risk Register Activity etc.)

2. Manage/lead Strategic Company Project Role as quality representative in project

• Local CMO optimization (If applicable)
• Perform GMP assessments via GMP audits etc., Identify suitable CMOs from quality perspective, develop good relationship with CMO(QA) aside with SCM team and closely communicate with CMOs to comply with GMP requirements
• Clean up legacies (2023-) (all QA members involvement)
• Close Long open cases in TW and GQP records (Deviation, change management, etc.) appropriately *As of 2024 Q2, almost cleaned up has been completed already except change management cases.
• If others, it could be handled.

3. Establish, maintain　and　improve　GQP quality　system/company QMS fulfilled the requirements from applicable laws and　corporate & local pharmaceutical standards.

• GQP QM systems
• EDM: Veeva Quality One Docs
• Learning Management System: LMS
• Quality Management System: TrackWise
• Other applicable system: Artwork control system etc.

4. Implement stable supply of appropriate quality product to Japanese market via supervising and communicating with oversea/domestic manufacturing sites (for API, formulations, Packaging, external lab, important suppliers) and SNO/local SCM team *SNO: supply network organization at Ferring global/regional.

5. Regulatory Compliance Activities

• Communications with health authorities (TMG, PMDA, MHLW) *TMG: Tokyo Metropolitan Government for various topics
• GMP Compliance inspection as to support Manufacturing sites as (domestic) representative as MAH
• Foreign Manufacturing Accreditation maintenance/newly application (FMA)
• MF maintenance (as to support CMC, RA team)

6. Ensure the realization of Goals and Objectives with priorities based on departmental and Ferring Japan’s strategy

< Required Education/Qualifications/Skills: >

Hard skills and experiences

<Mandatory>

• Over 3-5 years’ experience working in pharmaceutical industry and/or quality management such in Pharmaceutical Manufacturing Sites (QA, QC, Engineering/Validation, Productions and others)
• Familiar with GMP guidelines, regulatory requirements in pharmaceutical field (A beginner could be acceptable.).
• Japanese: Fluent
• English: Entry Business Level (e.g. TOEIC 650). However, as there is communication with overseas members, a highly motivation to equip communication English skill. (We have a lot of opportunities to train the staff in English skill via OJT (On the job training), but the motivation depends on the candidate.).

<Preferred>

• Bachelor’s or above degree in pharmacy, chemistry, biology or related field.
• Working experience in global, multinational environment.
• HQs ‘s quality functions (GQP, SQM and others). Not required: we can train the staff here who has a GMP background about GQP/SQM operations.
• English: Over middle Business level (Report and Collaboration with global members, attending a global conference, etc.)

Soft skills and experiences

• Strong logical and strategic thinking skill 高い論理的かつ戦略的な思考性
• Inter-personal skill　コミュニケーションスキル
• Accuracy and detailed oriented 細部への注意力、正確性
• Multi-tasking with speed and accuracy　マルチタスク（一定のスピード感と正確性を兼ね備えた）
• Action oriented with high autonomous 高い自律性と実践力
• Positive and constructive and proactive thinking　前向きで建設的かつ先見的な考え方

Attractive points

Provide the following opportunities via working experiences in this inspiring role.

From the view of organization size and existing products (approx. 20 SKU) and new product pipelines, given an opportunity to take a task in wider range of GQP activities to acquire comprehensive knowledge & skills for almost all elements of GQP activities.

• GQP Operational Skills and knowledge including regulatory perspective handling as well as QA perspectives
• Levelling up your English capability via frequent English communications in global organization.
• Experiencing frequent cross functional activities via a QMS role to learn a lot about GxP world in the phases from R&D to post marketing.
• Acquiring a wide field of view and a higher perspective with the frequent opportunities with direct communications with management (as beneficial small-mid size organization).
• Good working environment for “self-development” not required long time working (we are strictly controlled as department) and relatively easily take a Paid Time/Day Off (as always recommending taking appropriate PT/DO) to keep personal time for learning or other personal leisure. If you prefer to further deepen skills and experiences via work, it can be adjusted easily via priority.

Others:

The candidate's experience will be taken into account and the offer will be made in the position from senior staff to manager.

Location:Ferring Japan