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.
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
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
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
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:
GMP training on the schedule designated for role and as appropriate for role.
to strict compliance with procedures applicable to role.
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.
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.
an environment of employee engagement in the workplace.
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
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:
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.
to collaborate with and influence manufacturing site leadership teams
regarding prioritization and resourcing required.
to inform, communicate with, and influence Senior Management regarding
validated state of respective products/processes and indicated priorities required.
and application of pharmaceutical/OTC product and process development; life-cycle
management of this class of products including strategies for continuous improvement
and application of pharmaceutical/OTC manufacturing and formulation
technologies for liquid and solid dose manufacturing and product development
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.
to constructively challenge cross-functional project teams and business
partners to achieve project goals and global make strategic plans required.
collaboration, communication, and presentation skills required.
- Global Leadership Imperative
Leadership Imperative elements of major importance for this position are:
Johnson & Johnson K.K. (8235)Job Function