Quality Manager, External Manufacturing

ジョブ番号: 1033

外部説明:

Job Description

1. Quality Management of third-party manufacturers and suppliers

2. Quality Operations of EM CHC JAPAN Entity

3. Quality Training

4. Quality Technical Support

• The EM CHC JAPAN Senior Quality Manager (EM CHC JAPAN - SQM) shall manage the quality and compliance oversight of Contract Manufacturing Organisations (CMOs), third-party manufacturers and suppliers within the EM CHC AMEA – JAPAN entity according to the GxP requirements, international, and Sanofi global quality requirements.

• This role shall serve as the functional quality representative and ensure that CMOs / third party /suppliers are approved and that contracted Good Manufacturing Practices (GMP) activities are in compliance with international and local regulatory requirements, quality agreement, the registered dossier, and Sanofi global quality documents when applicable.

• This role shall ensure regular monitoring, assessment of records and results related to the contracted GMP activities. This role shall contribute to business operation by establishing partnerships and establishing trust with the CMOs / third party /supplier business partners and providing quality oversight and support for quality operations activities. This role shall escalate activities, issues, progress to Head of Quality EM CHC AMEA.

• This role shall assist in the establishment and continuous development of a robust Quality System of an appropriate standard and shall lead the key areas of Quality Assurance as applicable for the EM CHC AMEA - JAPAN entity in collaboration with the EM CHC AMEA – Quality Excellence Manager.

• This role will plan, organise and coordinate their workload and that of other Quality team members within the EM CHC JAPAN hub, so as to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines and to Sanofi Consumer Healthcare procedures. This role will have responsibility to ensure that their EM CHC JAPAN hub meets Quality Key Performance Indicators, in line with Organisational and Regulatory Standards and will take part in Quality and Regulatory Audits (if applicable).

• This role shall participate in and manage the Quality observations and Self-inspection program for the EM CHC JAPAN hub with a key focus on continuous improvement and efficient compliance. This role shall facilitate the empowerment of the EM CHC JAPAN hub Quality Managers / team members for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence of the Quality Documentation, Quality Systems Management and Quality Technical Support.

• This role will collaborate across the full EM CHC AMEA entity to assist and support leadership and Quality workload as required to drive continuous improvement and efficient compliance.

KNOWLEDGE AND SKILL REQUIREMENTS

• Language Skills:

- Japanese (Native level)

- English (Native, Fluent, Business Level)

• Experience & knowledge:

- At least 8 years working experience in quality or manufacturing in pharmaceutical industry
- At least 5 years’ experience within a Quality leadership or project management role

• Core competencies:

Strong Leadership skills including Influencing, mentoring, coaching and motivation of a team
Strong Pro-active, Planning, Organisational, Prioritisation and negotiation skills with a good sense of responsibility
Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
In depth knowledge of GMP (Japan, EU, ICH PIC/S) 
Balanced Judgment / Risk based approach
Ability to work in a matrix organization
Ability to work independently and write technical reports
Quality experience and knowledge within a cGxP, pharmaceutical environment
Internal and External Audit experience
Analytical thinking, Problem solving, hands-on troubleshooting, Risk assessment, and root cause analysis skills

ジョブ番号: 1033

コミュニティステータス: Quality Manager, External Manufacturing

Location_formattedLocationLong: Narita, Chiba JP