Website KBP Biosciences
KBP is a world-class biotechnology research & development organization dedicated to providing innovative therapies for unmet medical needs. Our integrated discovery and development platform enables us to efficiently bring new drugs from bench to clinics around the world.
Director (Senior, Executive) – Quality Assurance
JOB TYPE: Full-time
Summary of Position
Oversees the development, implementation and maintenance of quality assurance systems and activities. Develops and oversees a company-wide GXP system of Quality Assurance.
Utilizes quality tools such as lean, six sigma, risk management, and other tools to continually improve operations and to assure compliance with all appropriate federally-mandated requirements as well as industry benchmarks.
Monitors audits of Quality Control activities. Coordinates interdepartmental activities. May lead investigations and resolve potential product quality issues to improve efficiency. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Assures inspection preparedness and leads company representation during inspections.
- Functional leadership including managing vendor support.
- Knowledgeable about electronic Quality Systems
- Approve Deviations and CAPAs
- Provide support for audits and regulatory inspections
- Perform change control assessments Quality Systems including document management, change control, CAPA
- Develops and implements annual quality plans, departmental goals, action plans, and budgets according to KBP requirements
- Independently reports quality metrics to executive management through a management review process
- Responsible for talent management including recruitment, selection, development, training & retention of quality staff and ensures that proper quality skill sets and competencies are consistent with business and development plans
- Collaborates with process development, manufacturing, supply chain, commercial, translational sciences, corporate, and clinical groups
- Assures site quality training system is effective
- Ensures all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause
- Other duties as assigned
- Minimum experience of 10 years in a technical role in quality assurance, manufacturing, QC or quality engineering
- 5+ years of people and/or vendor management experience.
- Bachelor’s degree in engineering, chemistry, or biological sciences required. Advanced degree preferred
- Experience in pharmaceutical field required
- Extensive working knowledge of quality system requirements such as US FDA GXP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements
- Knowledge of fundamental quality principles such as process validation, process capability, process control, and structured problem solving
- Demonstrated ability to successfully interact with regulatory health authorities at inspections
- Ability to lead and influence cross functional employees to ensure compliance
- Ability to effectively present information in small and large group situations to staff, customers, regulators, and executive management
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Proficient in MS Word, Excel, Power Point