J&J Family of Companies Quality Assurance Director in Petaling Jaya, Malaysia

  • 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