Associate Director, GAIS US Regional Lead

WuXi Biologics•Worcester, MA

2d•Onsite

About The Position

This is a full-time position reporting to the Director, Global AIS SG & US team. The Global AIS US regional lead serves as a key member responsible for global automation integrated service (GAIS) activities across the US sites, including MFG18 (Cranbury, NJ) and MFG11 (Worcester, MA). This role will manage AIS activities and mobility SMEs in the US region including leading CAPEX projects, initiating Sustaining Improvement Programs (SIP), team development, compliance conformance, business planning, and global initiatives such as digitalization and WBS.

Requirements

Experienced and proven track record in establishing and managing an AIS function and team in a pharmaceutical or biologics facility.
Demonstrable ability to influence senior leaders, build strong relationships and drive a global AIS strategy.
Degree in Electrical, Instrument, Mechanical or Chemical Engineering, or other relevant degree BS with 15+ years or Master’s with 12+ years or PhD with 9+ years of experience in operation, technical service, or project management.
Prior working experience in chemical /biochemical industry; familiar with biologics drug manufacturing process.
Prior working experience within global company setup and culture; able to communicate and work across regions and time zones.
Must have strong customer service, coordination, and interpersonal skills; must have team leading and personnel management experience.
Proven ability to lead cross-functional and technical teams and align, motivate and empower team members.
Proficient with at least one major brand DCS /SCADA system and related deployment experience following GAMP5 validation.
In-depth understanding of facility construction project control and management, MEP, commissioning, and handover requirement.
Good knowledge on key process equipment in a typical DS or DP facility.
Basic IT knowledge.
Good familiarity and learning experience with industry 4.0 framework, IIOT, advanced analytics and Digitalization/AI tools.
General knowledge on GMP regulation and requirements; familiarity with BPE (Bioprocess Equipment) Guide is a plus.
Strong communication and leadership skills.
Ability to supervise, coach and develop staff to meet higher standards.
Ability to work well within a cross-functional team to achieve a common objective.
Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
Be collaborative and inclusive in your approach to work and your colleagues.
Autonomous and a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.
Drive a Continuous Improvement Culture within the Global AIS US regional team around strategies, execution and management of works.
Must be willing to travel as required within US and/or internationally to fulfil the responsibilities of the position.

Nice To Haves

Familiarity with BPE (Bioprocess Equipment) Guide is a plus.

Responsibilities

Lead SIP (sustaining improvement program) team and technical SME’s of Global AIS in the US region to provide capital project delivery together with GAIS project manager.
Provide post-construction support and continuous improvement to WuXi Bio and affiliation’s development and Manufacturing business through automation, digitalization and advanced Operational Technologies.
Develop regional business’s automation and digitalization plan, budget and roadmap.
Present ROI for new CAPEX project, and provide oversight on the quality of project delivery.
Maintain and improve client relations and facilitate stakeholder communication; provide technical solutions and proposal to customers; prepare progress report for management review.
Lead or facilitate engineering standards of automation aspect; automation related SOPs harmonization, common automation related training across WuXi Biologics
Lead or facilitate internal capability development, such as new technology introduction, premium service establishment, and new product development that can contribute to company’s value stream.
Support global tech forum for best practice, technology sharing, global policy alignment to form strong global -local AIS community.
Support external or internal audits to local sites in terms of audit preparation as well as prepare SMEs to face the audits.
Coach and keep growing the team’s technical competence and service capability
Active participation in strategic planning and business processes to shape company vision and goals.
Providing insights and recommendations that align with long-term objectives.
Will act as a role model for the global AIS function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Regular inter-departmental meetings and workshops to align teams with strategic direction.
Managing, navigating and resolving inter-departmental challenges/priorities for the best interest of the company.
Working closely with local sites and above site senior leaders from manufacturing, quality, engineering and regulatory affairs and automation/digitalization needs to identify improvement areas and align efforts.
Developing and implementing SIP strategy at both regional and global level; Identify improvement opportunities and turn opportunities into executable projects with improvement goals for more automated process, better data management and compliance, and higher equipment robustness and availability.
Utilizing WBS, Lean and Six Sigma methodologies to enhance operational performance.
Leading and participating in cross-functional initiatives to drive efficiency and innovation.
Responsible for the on-going Global AIS team development through coaching and mentoring and continuously improving the capabilities of the team.