CMO Quality Manager
- Tokyo, Japan
Site Name: Japan - Tokyo - Akasaka
Posted Date: Jun 23 2020
Reporting to the CMO Quality Group/Cluster Leader, as a key member of the Supplier Relationship Team (SRT), this position is responsible for managing the relationship with assigned Contract Manufacturers (CMs) in the Region from a Quality perspective to ensure GSK's product quality and reputation is protected.
In this role
- you ensure that all aspects of the products at assigned Contract Manufacturers comply with the requirements of the GSK Quality Manual and meet relevant cGMP regulatory and legislative requirements, through defined key performance and quality indicators,
- you assess the risk, identify gaps and implement quality action plans at assigned CMs and you communicate to the organization so the risks are proactively addressed
Additionally this role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CM(s). These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.
The CMO Quality Manager in partner with the Supplier Relation Manager (SRM), must develop and maintain an effective working relationship with internal stakeholders and all members of the SRT, including other members of CMO including Supply and Procurement Managers, as well as contacts within Regulatory, Technical, Procurement, relevant Category Quality functions.
- Be the point of contact for Quality matters with the assigned Contract Manufacturers.
- Ensure that all aspects of the GSK products at assigned Contract Manufacturer(s) comply with the requirements of the GSK Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
- Evaluate effectiveness of the CMO's Quality Unit and systems and influence External Suppliers promoting robust systems under self-sufficient organizations. Escalate all serious cGMP/Regulatory compliance issues. Monitor the quality performance of the External Supplier driving remedial action where necessary. Monitor and assess External Suppliers' key performance indicators, such as complaints and Right First Time as a mechanism to propose Continuous Improvement initiatives.
- Apply appropriate Risk Management tools with each CM/External Supplier in scope, escalating and tracking significant risks requiring resolution, including complaint monitoring and trending, reporting to Quality Council, Product Incident Review Committee (PIRC) or other Corporate Governance processes, as required.
- Ensure that investigations associated with assigned Contract Manufacturers are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure. Support the internal audit process where required.
- Ensure timely communication of Quality Alert issues. Co-ordinate and track any remediation deemed necessary. Ensure the LOC (Market QA) is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
- Drive periodic review of Quality Systems at the CM, to complement audit process. Conduct root cause analysis reviews for identification of issues and development of remedial actions.
- Review and respond to External Supplier regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to the associated agency.
- Work with CM to establish meaningful CAPAs, in response to GSK audit observations and assure acceptable closure with the CM. Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned Contract Manufacturer(s). Take the lead to ensure that any commitments given to address audit observations (both GSK and Health Authority) by assigned Contract Manufacturer(s) are implemented as described in the agreed time frame.
- Ensure that the list of material, products, contract manufacturers and suppliers is constantly up-to-date in relevant IT database (Carisma 3).
- Support new product introductions from an operational perspective. Eventually review and approve significant documentation associated with the introduction or transfer of a new or existing product to CMs,.
- Ensure that central database like TIMS are kept up to date for Quality section.
- Perform technical release of Medical Devices as per GSK procedures, if applicable.
- Be able to share expertise and functional knowledge to carry out day to day activities effectively on the relevant manufacturing processes (e.g. Solid forms, derm/liquids, nutritional, sterile, biopharm, medical Devices, toothpastes) and to perform varied work activities with some individual responsibility or autonomy under limited supervision with regards to packaging processes (e.g. Blisters, tubes, bottles and aseptic filing) and analytical processes (e.g. Physico-chemical and microbiology
Minimum Level of Education
- Degree in a Science or related discipline
- Graduation in Chemistry, Pharmacy, Microbiology or another related science, business degree is a plus
- Area of Specialisation
Broad and thorough technical, quality and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processes
Preferred Level of Education
- Master or PhD and at least 5 years experience AND/OR equivalency in education and experience.
- Area of Specialisation
Science, Pharmacy, Chemistry, Biology, Microbiology, Food and Nutrition
Minimum Level of Job-Related Experience required:
- 5 years experience in various Technical and Quality Assurance roles.
- Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
- Previous assignment experience promoting or requiring global perspective desirable.
- Project Management skills and leadership skills
- Operational Excellence exposure.
Other Job-Related Skills/Background
- Demonstrated ability to be assertive.
- Demonstrated sense of urgency, to complete the investigations including all necessary information to make decisions on batch disposal.
- Breadth in Quality Systems principles and practical application.
- Good knowledge and demonstrated application of Quality and Risk Management principles and tools.
- Demonstrated sound decision-making process; based on facts & data, and application of Risk Management principles.
- Technical knowledge of multiple dosage forms.
- Demonstrated ability to effectively prioritize work.
- Demonstrated ability to excel at execution. Analytical and conceptual thinking required. Effective and sustainable solutions should be provided.
- Excellent verbal and written communication skills; with strong presentation skills.
- Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
- Strong problem solving skills, with a disposition for continuous improvement.
- Demonstrated ability to work and collaborate in cross-functional teams.
- Demonstrated intercultural skills. Capability to work with diverse and wide spread team.
- Demonstrated commercial acumen to effectively work with external companies
- Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands.
- Capable of working independently. Ability of good judgments and to make independent decisions.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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