The Quality Director is responsible for leading and managing the development, implementation, maintenance, and evaluation of quality systems and processes throughout the organization. Ensures the company meets quality standards set by regulatory agencies, ISO9001:2015, compendia (e.g., USP), and customer requirements. This position is also responsible for ensuring that quality practices are in compliance with applicable standards, regulations, and procedures.
JOB DESCRIPTION
Develop and implement quality assurance and quality control policies, procedures, and objectives to ensure compliance with customer requirements, applicable regulatory standards, and ISO requirements.
Lead, manage and develop the Quality Assurance/Quality Control teams.
Develop and maintain a thorough understanding of company products and processes to correctly analyze and interpret customer problems and facilitate the implementation of corrective actions and process or product improvements.
Stay abreast of regulatory requirements and changes, ensuring the company’s compliance with applicable local, national, and international regulations.
Foster continuous improvement efforts.
Define the QA department goals and metrics.
Chair quality management review meetings.
Analyze and report quality metrics, trends, and performance to the CEO, Board of Directors, and Sr. Leadership Team.
Establish and maintain relationships with customers, vendors, and regulatory bodies to ensure adherence to standards.
Collaborate with Procurement to monitor supplier performance and to develop, implement and maintain the supplier auditing processes.
Collaborate with QA management at other company sites to ensure alignment of quality procedures and continuous improvement opportunities.
Serve as a liaison between the organization and external parties.
Oversee the organization’s ISO management system and liase with the ISO registrar to ensure relevant registrations are maintained and internal measures are properly managed, reported, and maintained.
Partner with R&D and Operations to ensure proper quality assurance and control plans for new products or manufacturing processes are implemented prior to beginning manufacturing.
Oversee the implementation of the of DQ/IQ/OQ/PQ process for new process or new equipment implementation projects.
Partner with Marketing to ensure customer facing product technical information is reviewed regularly and updated as required.
Partner with HR to evaluate appropriate staffing levels of department, conduct performance reviews, and to mentor and coach the team to further develop knowledge, skills and abilities.
Develop and implement quality training programs for both management and hourly employees.
Foster and maintain a quality culture within the organization.
Develop and manage the department budget.
JOB EXPECTATIONS
It is expected that the employee will dedicate personal time to further his or her education as it relates to work at company. This should include time spent reading relevant trade publications, journals, and text books.
On average employment will require 40+ hours per week.
Occasional travel will be required internationally and domestically.
Strive to continuously build knowledge and skills and share expertise with others.
Adherence to Company’s Code of Conduct and Professional Ethics Standards.
DESCRIPTION OF CANDIDATE:
Demonstrate integrity and professionalism.
Demonstrate excellent decision making skills.
Demonstrate strong management skills with the ability to drive competency and deliver information at all levels within an organization.
Demonstrate a positive attitude in the face of challenges.
Maintain a professional demeanor both internally and externally with vendors, customers and suppliers.
Maintain a high attention to detail to ensure compliance to standards.
Self-motivator and excellent problem solver.
Ability to work individually as well as positively and proactively in a team.
Reacts with an appropriate sense of urgency to production and customer needs.
Ability to communicate and work well with all levels of the organization.
Demonstrate strong communications skills: oral, written, electronic, and presentation
Able to provide a track record of accomplishment in managing multiple competing priorities on tight timelines.
QUALIFICATIONS OF CANDIDATE
Bachelor’s Degree or higher in a scientific or engineering related field.
Twenty (20) + years’ Quality Management experience in a pharmaceutical, biotech, medical device or disinfectant chemistry manufacturing environment.
Experience ensuring compliance with International, Federal, State and local regulations, and more specifically FDA regulations, cGMP standards, and ISO 9001, ISO 17025, ISO 11137, ISO 13485, and ISO 14001 requirements.
Demonstrated ability to lead successful process improvement initiatives using continuous improvement methodologies and root cause analysis.
Proven leadership skills to mentor, develop and improve the knowledge, skills and abilities of the QA/QC departments.
Strong project management skills with the ability to prioritize tasks, meet deadlines and manage multiple projects simultaneously.
Experience with risk management a plus.
Six Sigma Black Belt or Green Belt certification preferred.
Familiarity with EPA and/or BPR regulations for disinfectant products preferred.
Experience with contamination control principles required.
Experience with microbiology and environmental monitoring of controlled classified areas a plus.
Experience with cleanrooms and aseptic processing a plus.
PHYSICAL REUQIREMENTS
Hands to finger, feel, and handle testing equipment and product; operate computer.
Frequent standing, walking, sitting, reaching with hands and arms.