CMO Quality Manager
- Bangkok, Thailand
Site Name: Thailand - Bangkok
Posted Date: Mar 31 2021
Are you looking for Contract ManufacturersQuality Management role ? If so, this role could be an exciting opportunity to explore.
CMO Quality Manager is a key member of the Supplier Relationship Team (SRT) and is responsible for managing the relationship with assigned Contract Manufacturers (CMs) in the Region to ensure GSK's product quality and reputation is protected.
This role will also be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CM(s) to ensure their awareness and accountability on agreed key performance and quality indicators.
- 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, nutritonal, 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).
We are looking for professionals with these required skills to achieve our goals:
- Legally work in Thailand
- Bachelor Degree in a Science or related discipline, Master Degree is a plus
- Graduation in Chemistry, Pharmacy, Microbiology or another related science, business degree is a plus
- 8 years experience in various Technical and Quality Assurance roles.
- Experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
- Experience promoting or requiring global perspective desirable.
- Project Management skills and leadership skills
- Operational Excellence exposure.
- Excellent verbal and written in English skills
Other Job-Related Skills/Background
- Breadth in Quality Systems principles and practical application.
- Good knowledge and demonstrated application of Quality and Risk Management principles and tools.
- Decision-making process; based on facts & data, and application of Risk Management principles.
- Technical knowledge of multiple dosage forms.
- Ability to excel at execution. Analytical and conceptual thinking required.
- Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
- Capable of working independently. Ability of good judgments and to make independent decisions.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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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