Director of Quality & Technical Services (Project Management)

Summary: 

Oversight of Quality Systems implementation and management; audit support; Quality Assurance and Quality Control operations; and compliance for the Fiber Business Group in accordance with established practices, processes, regulations, guidelines and standards in a safe and efficient manner.

Essential Duties and Responsibilities:  

Other duties may be assigned.

Abide by, enforce and participate in the implementation and ongoing oversight of all company safety standards and regulations.

Take leadership and ownership of Quality, ensuring product design Quality relative to manufacturing and product safety, and regulatory compliance.  

Develop and maintain the business group's Quality Program and oversee quality management systems (CAPAs, Change Controls, Deviations). Maintain a corrective action and preventive action (CAPA) program to ensure that potential problems and root causes for deviations and non-conformances are identified, possible consequences assessed, and actions to prevent recurrence considered.

Lead and take total responsibility for implementation of Quality policy and procedures for the business group. Formulate quality policies and quality control of laboratory and production efforts. Author and/or review Quality Standard Operating Procedures, ensure that operating procedures, work instructions and guidelines describing the processes applied by the department are maintained up-to-date to reflect current practice and are consistent with industry standards and regulations. Develop, review and/or approve new and revised procedures or specifications; schedule and perform periodic review of controlled procedures to ensure regulatory compliance. Review and monitor performance of quality systems to ensure effectiveness and efficiency.

Provide strategic oversight and leadership to meet functional and business unit goals and objectives. 

Review and participate in the development of product specifications.  Provide oversight and support in the translation of product specifications to appropriate manufacturing instructions and documents. 

Oversee and/or lead root cause investigations into Quality issues, with corrective and preventative actions. Investigate or authorize an investigation related to any complaint concerning a company product or materials used in the manufacture of product. Recall product, when warranted.

Prepare, review and/or approve the Declaration of Conformity for all medical devices.

Ensure proper review, approval and change management to any procedure, specification, manufacturing procedure or process, equipment, instruments, test method, and validated system with potential impact on product and or process quality.

Responsible for QA oversight and compliance of qualification and validation activities of the various business group facilities. Review and approve all validation master plans, validation protocols, and validation reports generated by or for the business group.

Oversee the management and maintenance of relevant quality-related information systems, including but not limited to the specifications database, complaint investigation records and tracking of non-conformances.  

Develop and manage the internal/external audit program. Qualify suppliers/vendors, and contract organizations. Maintain audit schedules and control audit reports. Host non-regulatory and regulatory, directed and for cause audits/inspections related to GMP or quality systems and programs. Oversee and participate as necessary, in regulatory inspections at contract organizations when the inspection relates to GMP or quality systems related operations being performed. Analyze audit trends, implement corrective action and report on such trends.

Ensure compliance with regulations in all relevant markets to protect the company against regulatory action. Prevent issues that may affect the company through analysis and preparation. Ensure that facilities and personnel are prepared for, able to support and/or lead regulatory inspections and third party audits. Understand and use customer/consumer feedback and by monitoring industry wide technical and regulatory trends. Ensure appropriate preparation for, management of, and response to regulatory inspections to deliver the optimum outcome for both the company and its customers.

Maximize the utilization of quality resources to insure compliant, cost-effective, and on-time delivery of services and products.

Develop and manage key quality metrics for performance improvement of all areas. Ensure robust measurement and reporting tools are developed to enable accurate and timely reporting to senior management. Champion quality metrics to ensure targets are achieved, met and countermeasures in place when applicable.

Ensure appropriate GMP and QA systems training of department and QA personnel, suppliers and relevant customers, including but not limited to GMP and related training activities.

Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks and to maintain effective operations to support business needs. Support manufacturing facilities within the business group with their Quality Improvement process by giving constant feedback based on customer and consumer feedback. 

Ensure an empowered, effective and efficient quality organization that is staffed with competent personnel having the appropriate level of experience and expertise. Retain and develop personnel responsible for the management of quality operations to ensure the compliance of the company's products & operations. Motivate and lead a high-performance team. Attract, recruit, retain and develop members of the technical services team in accordance with strategic and succession plans. Mentor and develop subordinate managers and staff.

Provide effective and meaningful communication regarding issues, objectives, initiatives and performance to plan. Notify and update Operations Management and Executive Management of all product quality related issues and participate in the evaluation and continuous improvement of Quality Management Systems. Communicate quality assurance, management and control information to all relevant organizational departments, outside vendors, or contractors. Respond to customer inquiries and requests for information related to quality. Lead Quality review meetings.

Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality assurance, management and control.

Qualifications: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's degree in a scientific discipline, pharmacy or engineering from a four-year college or university,  preferably Chemical Engineering or Chemistry, and over ten (10) years of progressive experience and demonstrated successes in textile, fiber, medical device or pharmaceutical manufacturing industries, including minimum five (5) years of leadership of a Quality Department, or equivalent combination of education and experience. Quality Operations/Quality Systems knowledge and experience with FDA QSR's, CE Mark Harmonized Standards & other certifying bodies, and experience interacting directly with FDA and other certifying or regulatory agencies is also required.

Ability to read, analyze, and interpret the most complex documents.  Ability to respond effectively to the most sensitive inquiries or complaints.  Ability to write speeches and articles using original or innovative techniques or style.  Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

To perform this job successfully, an individual should be proficient in:

MS Office Suite, Enterprise Resource Planning (ERP) software, and AFIS.  Expertise in using Excel for data analysis and data presentation.

Professional quality certification (GLP/GRP/GMP), Lean/Six Sigma certification, preferred

This position requires specific knowledge in the following areas to be successful:

• FDA regulations, global quality regulations and requirements, contract manufacturing, GMPs, Internal and External Auditing.
• Ability to work at both a strategic and tactical level.
• Raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
•  Principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects. 

Supervisory Responsibilities:

This job supervises managers and staff in the Technical Services Department.  Personnel supervised may hold job titles such as Process Engineer, Process & Quality Engineer, Process Technician, Technical Services Laboratory Technician, Administrative Assistant/Document Specialist, etc.

Barnhardt Manufacturing Company is an Equal Employment Opportunity Employer (EOE/including disability/vets)

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