Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Quality Assurance Director
Petaling Jaya, Malaysia
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.
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
- 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
Johnson & Johnson Sdn. Bhd. (8275)