Requisition ID: 1805664199W
The Manager, Cluster Lead, Global Tech Ops Asia Pacific provides overall technical support to manufacturing operations groups within one of the five clusters of the Asia Pacific region.
Function holder partners with the tech ops global strategy and governance group and with internal Manufacturing management and Quality Assurance partners in the region to identify, prioritize, and execute technical projects including technology transfers, process capability improvements, and compliance remediations impacting cost, compliance, and customer service. Encourages and supports the identification and development of innovative solutions to problems and opportunities.
Function holder also assumes responsibility for solids and liquids projects across the regions. Occasionally, the function holder will support other clusters in the Asia Pacific region as the need arises.
The position has direct responsibility for collaboration of technical and functional resources to drive continuous improvement and consistency in tech transfer and manufacture of solid and liquid dose OTC products/processes. The direction from this position will have a significant impact on revenue growth, quality improvements, compliance remediations, and cost reduction for the OTC business within the cluster.
Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, the position responsibilities include:
- Ensure quality and compliance in all actions:
- Attend GMP training on the schedule designated for role and as appropriate for role.
- Adhere to strict compliance with procedures applicable to role.
- Exercise the highest level of integrity in the tasks performed.
- In a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace.
- Embrace a behavior of employee involvement and commitment to doing the job right the first time.
- Ensuring employees under the position’s scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
- Promoting an environment of employee engagement in the workplace.
- Seeking prompt identification, reporting and correction of deviations in the workplace as noted by employees.
- Lead consistent approaches and processes within the cluster and align with best technical policies and procedures across the Asia Pacific region.
- Provide direction for and review the progress of key projects impacting revenue growth, quality improvements, compliance remediation, and cost reduction. Ensure clear identification of project goals and the benefits to be realized. Effectively collaborate with cross-functional leaders to optimize business results. Provide guidance to resolve issues impacting timely completion and achievement of project goals.
- Collaborate with Platform leads and partners to deliver Enterprise value through standardization of key processes including, but not limited to, Tech Transfer, Characterization, and Validation.
- Support effective product lifecycle and knowledge management in close collaboration with the Global Technical Leaders and technical need state leaders. Align with the global and regional value stream priorities.
- Manage the performance of temporary labor and contractors as required to complete work in a compliant and timely manner.
- Partner with Research and Development to establish and maintain processes for planning, developing, and commercializing new products resulting in well-characterized, validated, highly capable, cost effective manufacturing processes.
Education: Bachelor’s degree (or equivalent) in Chemistry, Pharmacy, or Engineering is required. M.S., or Ph.D in Chemistry, Pharmacy, or Engineering is preferred. Reference experience minimums noted below.
Experience: 8+ years of industry experience is required. Relevant experience includes product/process development of pharmaceutical/OTC /Medical Device products, manufacturing of pharmaceutical/OTC/Medical Device products; R&D, Technical Services, Engineering in pharmaceutical/OTC field.
Physical Demands: Office deskwork, requiring sitting, walking, using phone & computer. May lift up to 30 lbs occasionally. This role may require up to 25% travel based on business needs.
Knowledge, Skills and Abilities:
- In depth knowledge and application of FDA, ICH and other applicable regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical and OTC products required.
- Ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing required.
- Ability to inform, communicate with, and influence Senior Management regarding validated state of respective products/processes and indicated priorities required.
- Knowledge and application of pharmaceutical/OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement required.
- Knowledge and application of pharmaceutical/OTC manufacturing and formulation technologies for liquid and solid dose manufacturing and product development required.
- Ability to provide technical leadership in problem-solving and decision-making; to collaborate with and influence business partner leaders with a focus on data, science, and technology required.
- Ability to constructively challenge cross-functional project teams and business partners to achieve project goals and global make strategic plans required.
- Strong collaboration, communication, and presentation skills required.
- Global Leadership Imperative Requirements: The Leadership Imperative elements of major importance for this position are:
- Problem Solving
Johnson & Johnson K.K. (8235)ジョブ