Manager, Quality Assurance

This is a key middle management role with both local and global impact at Ferring Pharmaceuticals, offering a unique opportunity to contribute to both local GQP/QA operations and global Quality Management System (QMS) initiatives and the operations. In addition to core responsibilities, the role involves leading strategic projects that shape the future of Ferring. Reporting to the Head of Quality, Japan, this position provides visibility across global quality functions and a platform for meaningful influence and career growth.

Strategic Impact: Influence both local and global quality decisions and business contributions through quality operations.

Cross-Functional Collaboration: Work closely with SCM, RA,CMC and global teams

Career Growth: (1) High visibility and leadership opportunities within a global pharmaceutical company and English and Cross-boundary communication skills via daily Quality operation(/OJT)

(2) Furthermore, based on the candidate’s capabilities and development, this position could lead to future opportunities as a potential successor for key leadership positions such as Head of Quality or Quality Responsible (GQP-Hinseki). It offers a clear path for professional development and a chance to play a meaningful role in shaping the company’s quality strategy and the operations.

Innovation & Change: Be at the forefront of new product launches and quality transformation

Our Product Portfolio: Ferring’s product portfolio in Japan spans highly specialized therapeutic areas, including reproductive medicine, urologic oncology, enuresis and endocrinology, and gastroenterology. These products are manufactured under a global quality management framework and meet Japan’s GMP and regulatory requirements, ensuring stable and reliable supply.

As one of the quality staff in the Japan Quality team plays a key role in supporting this reliability--through oversight of manufacturing sites, change control, and continuous quality assurance--contributing directly to the safe and consistent delivery of trusted therapies to healthcare professionals.

A. GQP Operational Roles & New Product Introductions

As part of the GQP responsibilities under the MAH, this role covers the full scope of GQP operations for Ferring products, including:

• GAP analysis between MFG and Testing process stated in the regulatory file and actual activities performed at MFG site (SOGO TENKEN)
• Change Management (Local change management activities)
• Quality Documentation
• Deviation and Complaint Management
• Oversight of local CMOs and overseas manufacturing sites (both internal and external)
• Supplier Quality Management (SQM), among others

These activities are essential to ensure full compliance with applicable GxP regulations in Japan(e.g., GQP and GMP ordinances) and global GxP guidelines , as well as corporate and local policies, standards, SOPs. In particular, with upcoming product launches, new products will fall under GQP control. The additional workload associated with these introductions will be effectively absorbed by the team through this new role.

B. Lead and Manage Strategic Projects and meeting bodies from a Quality Perspective

This role involves leading and managing local key initiatives to enhance quality operations and regulatory compliance. Key examples include:

• Local CMO Optimization Project
  Collaborate closely with the local SCM team to identify suitable key CMOs through structured assessments (as part of the SQM system). Once identified, provide appropriate quality and GMP guidance, and maintain close communication with the CMOs under GQP oversight.
• Preliminary assessment and early-stage project preparation related to potential changes
  Assess potential quality and regulatory impacts of changes such as site transfers, expansions, or major process modifications at overseas manufacturing sites. Based on global and local project information, work cross-functionally to investigate, define, and proactively communicate quality requirements in line with Japanese GMP and related regulations.

Additional key initiatives may be assigned as needed, with a focus on maintaining high standards of quality and compliance.

C. QMS related role

This role goes beyond the local GQP/QA function, serving as a key Site Quality representative within the Global Quality organization. It plays a pivotal role in shaping, implementing, and sustaining both corporate and local quality policies, along with the associated Quality Management Systems (QMS).

These systems include, but are not limited to: As general system (Adopted e-system)

• Document (Veeva) and Change Control (TrackWise) – Ensuring robust governance over quality documentation and controlled implementation of changes.
• Training Management (LMS) – Facilitating competency through structured training programs and compliance tracking.
• Deviation and CAPA Management (TrackWise) – Driving continuous improvement by managing deviations and implementing effective corrective and preventive actions.
• Audit and Inspection Readiness (TrackWise) – Maintaining a state of readiness for internal and external audits, ensuring compliance and transparency.
• Quality Risk Management – Proactively identifying and mitigating risks to uphold product and process integrity.
• Supplier/Service vender Quality Oversight (TrackWise) – Ensuring quality standards are met across the supply chain through qualification, monitoring, and collaboration.
• Product Quality Review (PQR/APR) – Conducting periodic reviews to assess product performance and identify improvement opportunities based on manufacturing sites report.

Please note that this is provided as an example and is not intended to be exhaustive or limiting. We are not requesting that all of these actions be taken; rather, we are sharing this to illustrate the nature of our expectations and to support further discussion or evaluation as appropriate.

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

• GMP Manufacturing Sites(Oversea & Domestic) control including Change Manag Documentation (Quality Product Codes, QTA GQP SOPs) *QTA : Quality Technical Agreement “Hinshitu Torikime”
• Gap analysis between approval documents and actual MBR/BR in manufacturing process and analytical Spec and method (SOGOTENKEN)
• Quality Performance Indicator Monitoring (QPI) and Quality Risk Register Activity
• Product Release (if applicable, Depending on the level of experiences and knowledge)
• ement, 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)
• Other quality related tasks

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

• Local LSP/CMO optimization (If applicable)
• Technical transfers of manufacturing site and external QC laboratory
• Operational Process Modification and Optimizations
• Other relevant tasks may be assigned as needed.

• Establish, maintain　and　improve　GQP quality　system/company QMS that fulfills 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.

• 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.

• Regulatory Compliance Activities

Communications with health authorities (TMG, PMDA, MHLW) *TMG: Tokyo Metropolitan Government for various topics

MP Compliance inspection as to support Manufacturing sites as (domestic) representative as MAH

Foreign Manufacturing Accreditation maintenance/newly application (FMA) *The main handler is CMC team but QA provides support in the communication with oversea manufacturing sites

MF maintenance (as to support CMC, RA team)

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