Director of Quality

4 weeks ago

Lexington, United States Kindeva Drug DeliverySummit Biosciences Full time
Job DescriptionJob Description

Job Summary:
The Director of Quality will oversee all quality assurance and quality control processes at Kindeva Drug Delivery/Summit Biosciences in Lexington, Kentucky. This role is a management position and is responsible for maintaining and improving the company's quality standards and ensuring compliance with all regulatory requirements. The Director of Quality will report directly to the Vice President of Operations and will work closely with cross-functional teams to drive continuous improvement and maintain high levels of customer satisfaction.

Compensation & Benefits:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment

Responsibilities:
- Develop and implement quality control procedures and standards to ensure compliance with regulatory requirements and customer specifications
- Lead and manage the Quality Assurance and Quality Control teams, providing guidance and support to ensure efficient and effective operations
- Oversee and continuously improve the company's Quality Management System
- Conduct internal audits and ensure timely resolution of any non-conformances
- Act as the primary interface with regulatory agencies during audits and inspections
- Collaborate with cross-functional teams to identify and implement process improvements
- Provide regular reports and updates to the Vice President of Operations on the status of quality objectives and key performance indicators
- Develop and maintain relationships with suppliers to ensure high quality materials and products
- Develop and deliver training programs to ensure all employees understand and adhere to quality standards and processes

Requirements:
- Bachelor's degree in a related field, such as Life Sciences or Engineering
- Minimum of 10 years of experience in a quality management role within the pharmaceutical or medical device industry
- Strong knowledge of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP)
- Proven experience in managing and leading a team
- Excellent problem-solving and decision-making skills
- Strong communication and interpersonal skills
- Ability to work in a fast-paced and dynamic environment
- Attention to detail and ability to prioritize tasks effectively
- Proficient in Microsoft Office and Quality Management Systems software

EEOC Statement:
Kindeva Drug Delivery/Summit Biosciences is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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