The Director QC&S is the company’s quality compliance representative, responsible for designing and implementing a comprehensive quality assurance strategy, and accountable for adherence to relevant regulatory requirements and company SOPs. S/he will be responsible for building and supervising the Quality department staff. The Director QC&S champions continuous improvement efforts and defect reduction initiatives to establish an effective Quality Management System (QMS). The Director will oversee Quality Control, Quality Assurance and GMP/cGMP Compliance programs related to the development, manufacturing and packaging of nutraceutical and pharmaceutical products. S/he will establish, maintain, and ensure effectiveness of quality systems and operations to assure compliance in a GxP pertaining to GMP, GLP and GCP as well as relevant ICH, US and EU regulations. S/he will also also ensure the timely release of incoming product batches into the marketplace for sale, assisting CURE in meeting financial sales targets and ensuring that quality product is available to patients and customers.Internally this position interacts with all departments at CURE, in particular Manufacturing and Supply Chain. Externally this position interacts with Health Agencies, third-party logistics, wholesalers and distributors, industry organizations, consultants, vendors, and health care professionals. This position will interact with and oversee reporting to the Drug Enforcement Agency and required staff training for handling of controlled substances. S/he will lead routine Quality Management Reviews with the leadership team to report Quality KPI’s. S/he will prepare and file Annual Product Reviews with health agencies.
- Provides Quality Assurance input to strategic goals in the form of schedules, plans, and budgets
- Hires, manages and develops quality function personnel
- Leads as a change agent in fast-paced environment to promote flexibility, creativity, and accountability to ensure speed to market
- Leads and/or represents internal/external manufacturing Quality site management on behalf of CURE
- Establishes & maintains phase-appropriate Quality Management Systems
- Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals (Third Party Logistics-3PL).
- Creates and maintains validated process, equipment, and components including single use disposable systems
- Reviews and releases clinical and commercial manufacturing batch campaigns for drug product and nutraceuticals as well as final product packaging
- Supports process transfer and process engineering CURE’s technology platform products including process optimization, new product implementation, process transfer, scale-up, validation, risk analysis process characterization and troubleshooting
- Oversee GxP compliance for all aspects of CURE’s programs to support clinical studies and future product registration
- Provides GxP Quality Assurance oversight of all external vendors’ quality programs, including CMOs, Contract Testing Vendors, investigator sites, including maintenance of quality agreements
- Responsible for deviations, product complaint investigations and GxP archives
- Ensures the adherence to industry standards and practices when conducting root cause investigations
- Oversees and implements compliance auditing program to fulfill regulatory requirements
- Develops effective partnerships with internal staff and external organizations to help formulate and implement proactive regulatory compliance strategies and controls
- Tracks, evaluates, and manages production related quality data and leverage to improve product quality
- Participate in personal development and training sessions.
- Work in a safe manner that does not endanger yourself or co-workers.
- Strive to consistently uphold CURE Pharma’s core values.
- All other reasonable duties, as assigned.
- Bachelor’s degree in biological sciences or engineering (preferred) or business administration.
- Advanced degree preferred
Experience: Ten (10) or more years of progressively increasing responsibility with commercial pharmaceutical manufactured products and direct quality by design experience in Quality, Engineering, and/or Research & Development in the bio/pharmaceutical industry
Knowledge, Skills and Abilities:
- Demonstrated strong root cause analysis skills with industry tools such as Kepner-Tregoe (KT)
- Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality assurance design methodologies, project management, and product life-cycle risk management theory and practical application
- Direct 'hand's-on' drug product development experience
- Ability to work collaboratively within a diverse business environment and personnel base
- Strong leadership skills, including the ability to set and administer goals, provide positive, constructive, and consistent feedback respectfully, the capability to build positive relationships to improve business results, as well as coach, mentor and develop junior-level engineering staff
- Ability to work effectively within a team in a fast-paced, ever-changing environment
- Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization
- Ability to multi-task, prioritize, meet/exceed deadlines, and hold themselves, staff, and others accountable
- Strong organizational, strategic planning, and tactical execution/follow-up skills
- Ability to maintain regular and predictable attendance
ABOUT CURE PHARMACEUTICAL
Cure Pharmaceutical is a vertically integrated life science company committed to improving drug efficacy, safety and the patient experience through its proprietary drug dosage forms and delivery systems. CURE has an industry leading full service cGMP manufacturing facility and is a preeminent developer and manufacturer of a patented and proprietary delivery system (CureFilm™). CURE has developed an array of products in cutting-edge delivery platforms and partners with leading pharmaceutical companies. Our mission is to improve people’s lives by redefining how medicines are delivered and experienced.
Our comprehensive package of benefits for eligible employees includes the following:
• Competitive compensation package with stock options and bonus incentives for excellent performance
• Competitive group benefit program, including medical, dental, voluntary life, disability and vision insurance
• Company-paid basic life/AD&D, short- and long-term disability insurances
• Paid time-off program consisting of vacation, sick, holidays, floating holidays and company-designated shutdown
• Tax-advantaged savings plan (401(k))