Johnson & Johnson Careers

Quality Assurance Director

Petaling Jaya, Malaysia
Quality (Generalist)


Job Description

Requisition ID: 1805649577W

  • Provides overview or detailed communications to Q&C and cross-functional leadership on status of initiatives and issues.  This communication occurs at a plant-level, and occasionally at a regional-level.
  • Troubleshoots and solves high risk and high complexity issues, using experience, ingenuity and creativity to implement solutions across a wide range of root causes.
  • Lead the design and implementation of safety, Q&C, customer service and cost improvement programs and initiatives.  Innovate solutions to significant quality system gaps and lead continuous improvement projects.
  • Organizes, plans, leads and manages quality related projects in alignment with company goals.
  • Is accountable for product disposition and compliance decisions at the plant level.  Escalates when required by procedure, or when potential impact to safety, systemic compliance, customer service or at significant cost.
  • Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, design control, and quality systems.
  • Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.
  • Monitors supplier quality related activities to assure fulfillment of contract/purchase order requirements.
  • Facilitates the development and training of immediate staff.
  • Cultivates a culture of quality, acting as the voice of Q&C during plant-level interactions.  Has a high degree of shop-floor presence. Site Q&C is visible to employees at all levels of the plant organization as a Q&C leader.
  • Build strong interdependent and truly partnership with the local Operation, Local Operating Companies, global and regional leadership of Quality & Compliance, R&D, SMP, Technical Transfer, Packaging, Regulatory, CLS and ad-hoc project teams
  • Partners with industry leaders, and sector/enterprise senior technical stakeholders, to develop and implement best practices and improvement opportunities.
  • Identifies, recruits and develops high-performing talent. 
  • Ensures a strong pipeline of talent for leadership roles and critical positions. 
  • Develops new front-line supervisors. 
  • Manages performance of direct reports, and provides input to talent processes for all individuals in the Q&C organization at the plant-level.


Qualifications
Education:   Bachelor’s degree ; Masters preferred
Experience:  10+ Years of Regulated Industry Experience
Knowledge, Skills and Abilities:
  • Expert knowledge of cGMP requirements and current Health Authority (i.e. FDA, MHRA) enforcement issues across multiple regulatory classes (Rx, OTC, Cosmetic, Medical Device)
  • Demonstrated ability to lead cross-functional local teams, and participate in regional teams to accomplish business objectives, enhance relationships, and inform management to drive change and provide direct feedback.
  • Is knowledgeable to execute quality systems including risk management, investigations, change control and CAPA.  Has a working knowledge of at least one other system including production, packaging and labeling, facilities and equipment, materials or laboratory controls.
  • Regulatory Compliance
  • Cross Segment/Global working knowledge
  • Best-practice
  • Communication, Effective creative methods of cascading key message
  • Deployment  Strong Implementation & pull through
  • Challenging Sites,  Change Management
  • Business Related
  • Establishing Community of Practice
  • Managing the “Grey Space” application & interpretation
  • Understanding Impact
  • Solutions Oriented

Primary Location
Malaysia-Selangor-Petaling Jaya
Organization
Johnson & Johnson Sdn. Bhd. (8275)
Job Function
Quality (Generalist)
Requisition ID
1805649577W