Sr. Manager, Quality (Reg Comp&Systems) Job - Singapore
- Plan, manage and coordinate internal and external regulatory audit activities and program to ensure that drug substance and drug products of MSD Singapore are manufactured in compliance with current Good Manufacturing Practices, applicable international requirements, corporate and site policies and guideline.
- Manage and ensure timely worldwide registration of drug substances and drug products manufactured by MSD Singapore.
- Manage and coordinate the implementation of Quality Management Systems and Quality Risk management, integrate mitigation plan and technique based on product type and associated technology.
- Provide oversight on the implementation and management of Quality Automation Systems and site documentation system and ensure compliance to corporate and site policies and guideline.
- Lead and drive site quality culture
- Manage and ensure that MSD Singapore is compliance with current Good Manufacturing Practice and applicable international guideliens and corporate guidelines and policies
- Plan and manage preparation work for corporate and regulatory audits, including internal audits. Monitor and manage regulatory commitments made to regulatory agencies to ensure these are fulfill in a systematic, timely and accurate manner so as to ensure continued registration of MSD products
- Manage site quality council meeting and ensure on time collation of site/quality metrics for reporting to site and corporate management
- Support the roll out and manage effectiveness of corporate quality automation systems to ensure adequate system design, maintenance and control which is complying with the corporate policies of automation system lifecycle and internal requirements
- Ensure effective management of Quality Management System (QMS) implementation program and Quality Risk Management to ensure site compliance to corporate policies
- Ensure routine quality automation systems are managed effectively and complies with GMP and internal requirements.
- Provide an effective and efficient site SOP management system to ensure the developing, maintenance, control and distribution of SOP complies with regulatory and corporate requirement
- Provide effective management of a team of associates to deliver services which are lean, cGMP and business compliance.
- Proactively liaise and work with Regulatory Affairs, CMC on product submission filling strategy on behalf of site, assuring product filling is fit to its intended use
- Lead and participate in continuous improvement initiative as part of the MPS culture in MSD Singapore
- Apply statistical analysis and process control technique, and carry out appropriate troubleshooting, root cause analysis and problem solving techniques in all tasks
- Ensure an effective training systems for the area and provide direct reports with appropriate training for both technical and soft skills through learning course, job exposure and coaching and mentoring
- Participate in EHS, Business Compliance, cGMP and all other compliance related matters, where applicable
- Supervise and oversee third party contractors, where applicable.
- Provide coaching and mentoring for personnel and provide professional development of staff, through timely and effective staff appraisals
- Provide subject matter expertise on the practical application of ICH guideline. Applies QbD framework and principles in integration and adaptability of key quality system
- Provide functional ownership and accountability for the value stream, ensuring key performance indications (KPIS) are met for quality systems
- Develop effective and focused regulatory inspection preparation strategy to assure successful regulatory inspection outcome.
- Act as site expert on quality risk management
- Drive and implement site quality strategy initiatives
- Identifies and resolves technical and operational problems, collaborates with peers to resolve problems that cross into inter-related unit.
- Identify and integrate patterns, trends and inconsistencies across multiple data sources to determine their boarder implications
- Coach others in the use of problem solving tools and techniques encouraging others to think creatively to achieve new solutions
- Actively seek opportunities for improving quality department processes and increasing efficiency
- Bachelor Degree or higher in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience. Master's degree for qualification is desired.
- Audit experience preferred. Good knowledge of Singapore, US and European regulatory requirement.
- 10 years or more of relevant experience in a quality assurance and other function (e.g. operations, technical, etc.) in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
- Project management skill with good knowledge of system lifecycle management is preferred for the roll out of corporate automation system.
- Lean Expert
- Lead and drive quality culture.
- Ability to build, develop and lead high performance team, good people management and team working ability with people at all levels
- A continue improvement mindset
- Demonstrates the ability to develop and promote an environment that nurtures creativity and improvement of current ways of doing things
- Demonstrates active skill in challenging the status quo, offering practical alternatives
- Demonstrates the ability to actively seek opportunities for improving department processes and increasing efficiency
- Knowledge of systems and continuous improvement
- Project management skill is preferred for the roll out of corporate automation system.
- Possess good knowledge and application of Lean with excellent problem solving skills
Job: Regulatory Compliance Job Title:Assoc. Dir, Quality Systems & Compliance
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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