Quality Manager External Manufacturing Japan, エスエス製薬

Quality Manager External Manufacturing Japan, CHC

• Location: Japan
• 40% Remote working
• Job type: Permanent

About the job

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately,challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Our Team:

Manage third party manufacturers located in this region. Products are for local market and export markets. Perform regular monitoring and assessment of contracted GMPs activities.

Serve as functional quality representative of external manufacturing Japan for CMOs in work scope. Ensure that manufacturing operations are conducted, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.

Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activities

Any ad hoc tasks assigned by the reporting Manager

Candidate may be required to adjust work schedule as needed based on the time zone of stakeholder, have good communication skills to liaise with stakeholders across different time zones and be able to work collaboratively with a remote team.

Main responsibilities:

Quality Management of third-party manufacturers

• Perform GMP audits of third-party manufacturers and CAPA (Corrective action and preventive action) follow-up.
• Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
• Management and support for product recall and return.
• Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
• Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
• Participate in the evaluation, selection, and approval of third-party manufacturers.
• Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
• Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
• Review of technical reports e.g., stability reports, process /analytical validation reports etc.
• Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
• Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
• Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third-party manufacturers.
• Perform risk ranking of third-party manufacturers.
• Manage termination of activity with third party manufacturers.

​Quality Operations of EM CHC Japan Entity

• Support/perform management and continuous improvement of Quality Management System (QMS) in alignment with EM CHC AMEA & China.
• Support/perform implementation of global quality systems, standards and procedures.
• Support Quality Documentation System management, documentation Retention, Archival and Destruction.
• Support/perform Qualifications and Training of Quality/Regulatory personnel.
• Support/perform Self Inspection.
• Prepare and participate in EM CHC Japan / EM AMEA & China Quality Review.
• Support/prepare Monthly Quality Reports for reporting to Global Quality.
• Collect and consolidate the quality KPI’s (Key Performance Indicators) of third-party manufacturers for reporting to Global Quality.

Quality Support for Transversal Projects

• Provide Quality support for transversal project e.g., new product launch, site transfer or repatriation.

Others

• Any Ad Hoc activities as specified by the Reporting Manager

About you

Experience:

• Experience in quality or manufacturing in pharmaceutical industry.

Soft skills:

• Ability to work in a matrix organization.

• Good team spirit and familiar with project development through cross-functional activities.
• Strong organizational and negotiation skills.

• Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
• Pro-active with good sense of responsibility.
• Balanced Judgment / Risk based approach.
• Analytical thinking, hands-on troubleshooting style.
• Able to work independently and write technical reports.
• In depth knowledge of pharmaceutical/nutraceutical/cosmetics/medical devices GMP and regulations (ASEAN, EU, ICH, PIC/S, local market GMP regulations).

Technical skills:

• Computer skills: Word, Excel, Phenix / CONNECT (Quality tool and GMP Documentation system).

Knowledge And Skills Desirable but Not Essential:

• Technical knowledge for various dosage forms, active pharmaceutical ingredient, pharmaceutical, nutraceutical, cosmetics, and medical device.
• Knowledge of CMC regulatory affairs.
• Experience in GMP audits.
• Capable of interacting with the other Quality and regulatory departments and other EM counterparts
• Computer skills: Veeva Vault system (QMS system, Registration database and Regulatory tool for Dossier management).

Education:

Degree in Pharmacy / Pharmaceutical Science / Related Science

Languages:

The ideal candidate for this position must be fluent in both English and Japanese, as they will be required to communicate effectively in a business setting in Japan and with regional stakeholders and participate in global business interactions.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.