Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com ), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com ) with a mission to provide the highest quality materials to niche life science markets worldwide.
Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer.
Why Work Here?
Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more.
JOB SUMMARY:
Under strategic leadership and an integral member of the site leadership team, lead the Quality Assurance Business Unit to enhance business performance and drive positive continuous improvement culture. Partner with other Nitto manufacturing sites to achieve Same Products/Same Quality (SPSC) business objectives. Develop well-defined quality standards, specifications, and operator self-inspection methodologies to raise the performance of the company's product lines, promoting customer satisfaction, on-time delivery, and business excellence. Play key role in developing site business strategy, collaborating with Process Development, Engineering & Operations, Procurement and Human Resources Management.
ESSENTIAL DUTIES and/or RESPONSIBILITIES:
- Provides site leadership to meet and improve product quality and operation quality standards, engaging employees to achieve business objectives.
- Leads and manages the Quality team to achieve key indicator results supporting the business objectives, goals, and strategies.
- Directs department staff in the performance of their essential functions and complete related Human Resources activities, including recruiting, interviewing, selecting, coaching, mentoring, training, performance reviews and employee relations.
- Develops, manages, and sustains, the Quality Management Systems to meet applicable Regulatory requirements, such as ISO, FDA, QSR, US and INTL regulations and International Quality Standards, as applicable.
- Ensures customer quality satisfaction through the implementation and use of programs(e,g,MasterControl) to control raw materials, in-process materials, production processes, environmental conditions, and finished products to meet customer quality expectations and requirements.
- Secures timely closure of deviations, change controls, Corrective/Preventive Actions (CAPA) and complaints. Develops strategies for continuous improvement.
- Contributes to internal and external audit programs; ensures audits are completed accurately and within the deadline. Participates in third party external inspections/audits, serving as primary audit host for KLS.
- Manages a formal corrective action system to corroborate root cause analysis and continuous improvement (Kaizen) objectives. Assures timely responses to external and internal customer requests, statements of non-compliance, or complaints, and confirms appropriate corrective action.
- Plans and oversees analysis of statistical data and product specifications to determine present standards and monitors Quality and reliability expectancy of finished product.
- Partners with departments across the a cross-functional matrix & external stakeholders as appropriate and ensures senior leadership is informed of any serious complaints.
- Develops and delivers training programs that teach appropriate use of Quality Tools.
- Supervises and develops a team of Quality Assurance Supervisors and Specialists providing guidance, training, and support to ensure compliance with regulatory standards and best practices.
- Mentors and develops a team of the QA team, fostering an environment of accountability and growth. Ensures cross-functional collaboration and provide effective leadership managing the QMS processes and ensures effective employee relations.
- Executes training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce.
- Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team.
- Conducts performance evaluations of direct reports. Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations.
- Other duties as assigned.
SUPERVISORY RESPONSIBILITES:
- Quality Operations Supervisor
- Quality Systems Supervisor
- Quality Assurance Specialist (all levels)
- Quality Systems Specialist (all levels)
MINIMUM EDUCATION and/or EXPERIENCE:
- Bachelor of Science degree in a technical field or related subject; and 7-years' directly related experience in QA/QC position; Master of Science degree, a plus.
- Ten (10) years' leadership experience in a highly regulated manufacturing operations and quality assurance environment, preferably in the pharma industry; or an equivalent combination of education and experience.
KNOWLEDGE, SKILLS and/or ABILITIES:
- Demonstrated success in leading a hands-on quality culture and performance transformation focused on disciplines QMS management execution and a proactive quality culture of personal accountability, sound judgment, empowerment, and pride in performance.
- Working knowledge of regulations/guidelines in partner industries (such as ISO 9001, ISO 134385, ICH Q7, FDA 21 CFR Part 210-211).
- Demonstrated proficiency in managing the integration and deployment of lean manufacturing principles within an organization along with customers, required.
- Excellent working knowledge of Quality principles, concepts, methodologies, and techniques as well as chemistry concepts; above average understanding of solid support and oligonucleotide synthesis.
- Robust application of critical thinking skills along with exceptional problem-solving skills to identify root cause analysis.
- Clear multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment. Work in a detail-oriented environment with strong follow-through and organizational skills.
- Solid ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills and conflict resolution.
- Strong Microsoft Office Suite software applications such as Excel, Word, Power Point and other enterprise software applications like MasterControl or equivalent electronic Quality Management System.
- Strong language skills with the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations.
- Write clear processes, manuals and reports for management review and present technical information in understandable terms and respond to questions from groups of customers, employees and/or public.
- Work well in a small and/or large group and foster cooperation in a team environment using interpersonal skills.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram forms.
CERTIFICATES and/or LICENSES:
- Certified Quality Auditor, desirable.
PHYSICAL DEMANDS and/or WORK ENVIRONMENT:
(Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Position works in an office environment involving prolonged sitting in front of a computer workstation, speaking, listening, reading, and writing and low-level noise.
- Domestic and international travel to Japan, Asia, Europe, and the Middle East may be required, up to 10% of the year.
- Communication with overseas offices and/or customers in different time zones requires flexible availability, including early morning or late night, as necessary.
- Ability to work under demanding requirements and hard deadlines (e.g., product deliverables).
- Must be able to work extended hours per the demands of the business.
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