DEPARTMENT: Quality           

REPORTS TO:  Vice President of Quality

FLSA STATUS: Exempt

POSITION DESCRIPTION:

The Director, Quality Operations is responsible for providing quality leadership across the Flexan manufacturing plants to ensure that products produced are compliant to site and global standards.  The role will provide expertise and direction to the onsite Quality teams, ensuring successful production of products that are critical to the market, meeting all regulatory requirements.  The role will be responsible for managing and implementing the Quality Management System and processes across the organization.  This position oversees quality assurance and compliance functions and ensures integration throughout departments to ensure the Quality Management System (QMS) is compliant to standards and products meet quality specifications. This critical leadership position will instill ownership and accountability for the site quality objectives across the organization, through the continued development of high performing teams, with a passion for servant leadership for both our internal and external customers of the products we deliver to the market.

POSITION OBJECTIVE: 

The Global Director, Quality Operations, Flexan position is in place to drive harmonization across the sites around all Quality Management System (QMS) elements including Documentation, CAPA, Deviation, Change Management, Training, etc. The role will provide leadership to the site Quality teams in order to drive continuous improvement and accountability on all quality operations deliverables to ensure a safe and compliant product for our customers.

This position will be accountable for ensuring strong and consistent delivery of our products to our customers and will partner with business leadership to drive awareness of compliance and quality requirements of the products we sell.

The position requires expertise in quality management principles, leadership experience within cross functional teams including matrixed teams, and implementing quality control (i.e. test lab experience, method development and verification/validation, data integrity, compendial compliance) and quality assurance (i.e. QMS adherence) measures to ensure that GMP requirements are met through all stages of the production process.

The position will adapt and respond to the increasing complexities of the products we sell and the regulated markets we sell within and will continue to ensure the onsite teams can meet strategic plans and annual site objectives across Quality, Delivery, Safety and Cost measures accordingly.

This position leads and develops direct reports and cross-functional team members across the organization globally.

RESPONSIBILITIES :

• Provides strong leadership and guidance to the onsite Quality Site Managers across the portfolio of sites in the Flexan network.

• Leads the quality improvement initiatives and partners with the operations teams to ensure a culture of quality throughout the organization.

• Establishes quality metrics across the sites and uses data analytics to report out on the progress across the established measures.

• Performs gap assessments where required against quality and regulatory requirements and manages the actions required to mitigate gaps identified.

• Works collaboratively with all cross functional leaders that interact globally as well as are located onsite to ensure compliance and quality requirements are fully understood and implemented appropriately by the organization.

• Oversees maintenance of the requirements and monitors the effectiveness of the ISO quality system as well as drives continuous improvement and maintenance of the system.

• Oversees the management of the QMS to ensure compliance with relevant regulatory bodies. 

• Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees; communicates job expectations and leads team in talent and performance management processes.

• Responsible for understanding customer needs and requirements to develop effective quality control processes.

• Hosts customer and registrar audits, as well as coordinates and performs internal quality and supplier audits as needed.

• Leads all internal and external CAPA’s, NCR’s, change management tasks and customer complaints including investigation, root cause analysis, and other related documentation. 

• Ensures all document control and revision control activities are carried out to ensure compliance, ensures accountability for risk identification and mitigation/compliance for areas that impact quality in the product.

• Ensures all products conform to validated processes and DMR’s, as well as performs lot release where required and related functions.

• Manages the approved supplier list and ensures suppliers are managed appropriately through audits and other score card ratings.

• Ensures all SOP’s and process documentation are created in accordance with the QMS and works with all departments to ensure effectiveness.

• Embeds a culture of quality throughout the organization through interactions, education, and by example, ensuring quality in the product is a focus across all levels.

• Demonstrates both a process approach and data driven decision making to systematically and objectively improve company performance.

  EDUCATION AND EXPERIENCE

• Bachelor of Science degree program in Science or Engineering or a Quality related discipline.

• 12+ years experience in regulated Quality, including experience in both Quality Control and Quality Assurance, and 7 years experience specific to management responsibility.

• Knowledge in applicable regulations (ISO 13485, ISO 9001, 21 CFR 820, 210, 211) with progressive scope and responsibility in quality assurance, medical device/products quality systems experience preferable

• Ability to travel domestically and internationally (50%+).  Position requires travel to the manufacturing sites in the network to properly engage with the teams onsite.

• Proven successful ability in the following areas:

• Development of quality systems and processes, particularly in regulated areas

• Project management, driving quality initiatives on time and on budget

• Customer engagement in driving customer satisfaction in a regulated environment

• Leadership of direct reports at various levels of the organization including management and cross-functional leadership across quality related tasks

• Documentation creation and revisions as well as internal and external communications (written and oral)

• Root Cause Analysis in solving complex investigations and driving suitable CAPA for proper resolution

• Using data analytics to drive decisions as well as accountable ownership of improvements

• Must behave in a professional manner at all times; ability to use appropriate levels of tact, diplomacy, and discretion 

• Demonstrated strong time management skills; able to handle multiple tasks, set priorities and meet deadlines

• Ability to resolve conflicts; work well under pressure, act quickly and decisively using sound judgment

   

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